Regulatory Open Forum

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks 

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States
------------------------------

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Yes, but justifying, even with strong supporting evidence, and verifying can be two very different things.  Was this during premarket review?​

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

How do they determine whether the devices used in design validation were the initial production devices or their equivalent?  Just by asking?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 18-Feb-2019 17:01
From: Edwin Bills
Subject: Design Validation

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

In response to Julie's question:

It is like any other request of an FDA Investigator at an inspection, they ask for you to provide objective evidence which is documentary evidence of the devices used.  If they are equivalent then you must provide a comparison chart or document showing the differences and the impact of those differences on the final device that will be released to the customers.

If the devices used are production devices then you should be able to provide the DHR that shows the devices (including serial number, lot number or batch number) used were produced to the DMR of the final devices.  The DHR should include the actual label of the device, FDA does not like photocopies of the label, only actual labels.  

Of course the product used for Design Validation must include the actual packaging, labeling and instructions for use of the final device.  The validation activities should demonstrate the complete product can be used successfully by the user, and should include usability validation as part of the validation activities.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 18-Feb-2019 19:59
From: Julie Omohundro
Subject: Design Validation

How do they determine whether the devices used in design validation were the initial production devices or their equivalent?  Just by asking?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 17:01
From: Edwin Bills
Subject: Design Validation

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Thanks, Edwin.  Almost done, I think.

I don't think serial number, lot number, or batch number shows the devices were produced in any particular way.  I think that information is in the lot/batch records, correct?  Are these usually included in the DHR?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 18-Feb-2019 21:54
From: Edwin Bills
Subject: Design Validation

In response to Julie's question:

It is like any other request of an FDA Investigator at an inspection, they ask for you to provide objective evidence which is documentary evidence of the devices used.  If they are equivalent then you must provide a comparison chart or document showing the differences and the impact of those differences on the final device that will be released to the customers.

If the devices used are production devices then you should be able to provide the DHR that shows the devices (including serial number, lot number or batch number) used were produced to the DMR of the final devices.  The DHR should include the actual label of the device, FDA does not like photocopies of the label, only actual labels.

Of course the product used for Design Validation must include the actual packaging, labeling and instructions for use of the final device.  The validation activities should demonstrate the complete product can be used successfully by the user, and should include usability validation as part of the validation activities.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 18-Feb-2019 19:59
From: Julie Omohundro
Subject: Design Validation

How do they determine whether the devices used in design validation were the initial production devices or their equivalent?  Just by asking?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 17:01
From: Edwin Bills
Subject: Design Validation

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Julie,

The DHR is the production record that shows the device is produced in compliance with the Device Master Record.  The DHR provides records of both successfully produced product and non-conforming product and includes information on results of incoming, in-process and final inspection, distribution and records of any installation.  The DHR provides objective evidence of meeting requirements of the Device Master Record and provides information for investigations and corrective or preventive actions.  

The DHR must include at least dates of manufacturer or the lot, batch, or serial number; quantities manufactured; quantities released for distribution; and any identification or control numbers.  The actual primary label and labeling must be included, as well as any UDI information. 

So the lot or batch records you describe are a part of the DHR and are not separate from the DHR.  The DMR must include the blank forms that are used to complete the lot or batch records for the DHR. The DMR also includes all information necessary to walk into an empty facility and set up the production of a device.  So it includes all equipment specifications for manufacturing, inspection and testing equipment, as well as all device specifications.  It includes all manufacturing methods and procedures, quality procedures, and packaging and labeling procedures.  The DMR also includes any installation, maintenance and servicing procedures.  21 CFR 820.181 is quite specific in listing the requirements for the DMR.

Hope this helps.  It is part of the presentation we do in the AAMI Quality Systems course which goes into more detail of each of the records required by FDA in the QS Regulation.  It is also documented in AAMI's The Quality System Compendium, the text for the course.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 18-Feb-2019 22:38
From: Julie Omohundro
Subject: Design Validation

Thanks, Edwin.  Almost done, I think.

I don't think serial number, lot number, or batch number shows the devices were produced in any particular way.  I think that information is in the lot/batch records, correct?  Are these usually included in the DHR?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 21:54
From: Edwin Bills
Subject: Design Validation

In response to Julie's question:

It is like any other request of an FDA Investigator at an inspection, they ask for you to provide objective evidence which is documentary evidence of the devices used.  If they are equivalent then you must provide a comparison chart or document showing the differences and the impact of those differences on the final device that will be released to the customers.

If the devices used are production devices then you should be able to provide the DHR that shows the devices (including serial number, lot number or batch number) used were produced to the DMR of the final devices.  The DHR should include the actual label of the device, FDA does not like photocopies of the label, only actual labels.

Of course the product used for Design Validation must include the actual packaging, labeling and instructions for use of the final device.  The validation activities should demonstrate the complete product can be used successfully by the user, and should include usability validation as part of the validation activities.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 18-Feb-2019 19:59
From: Julie Omohundro
Subject: Design Validation

How do they determine whether the devices used in design validation were the initial production devices or their equivalent?  Just by asking?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 17:01
From: Edwin Bills
Subject: Design Validation

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Yes, it helps, thanks!​

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 18-Feb-2019 23:18
From: Edwin Bills
Subject: Design Validation

Julie,

The DHR is the production record that shows the device is produced in compliance with the Device Master Record.  The DHR provides records of both successfully produced product and non-conforming product and includes information on results of incoming, in-process and final inspection, distribution and records of any installation.  The DHR provides objective evidence of meeting requirements of the Device Master Record and provides information for investigations and corrective or preventive actions.

The DHR must include at least dates of manufacturer or the lot, batch, or serial number; quantities manufactured; quantities released for distribution; and any identification or control numbers.  The actual primary label and labeling must be included, as well as any UDI information.

So the lot or batch records you describe are a part of the DHR and are not separate from the DHR.  The DMR must include the blank forms that are used to complete the lot or batch records for the DHR. The DMR also includes all information necessary to walk into an empty facility and set up the production of a device.  So it includes all equipment specifications for manufacturing, inspection and testing equipment, as well as all device specifications.  It includes all manufacturing methods and procedures, quality procedures, and packaging and labeling procedures.  The DMR also includes any installation, maintenance and servicing procedures.  21 CFR 820.181 is quite specific in listing the requirements for the DMR.

Hope this helps.  It is part of the presentation we do in the AAMI Quality Systems course which goes into more detail of each of the records required by FDA in the QS Regulation.  It is also documented in AAMI's The Quality System Compendium, the text for the course.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 18-Feb-2019 22:38
From: Julie Omohundro
Subject: Design Validation

Thanks, Edwin.  Almost done, I think.

I don't think serial number, lot number, or batch number shows the devices were produced in any particular way.  I think that information is in the lot/batch records, correct?  Are these usually included in the DHR?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 21:54
From: Edwin Bills
Subject: Design Validation

In response to Julie's question:

It is like any other request of an FDA Investigator at an inspection, they ask for you to provide objective evidence which is documentary evidence of the devices used.  If they are equivalent then you must provide a comparison chart or document showing the differences and the impact of those differences on the final device that will be released to the customers.

If the devices used are production devices then you should be able to provide the DHR that shows the devices (including serial number, lot number or batch number) used were produced to the DMR of the final devices.  The DHR should include the actual label of the device, FDA does not like photocopies of the label, only actual labels.

Of course the product used for Design Validation must include the actual packaging, labeling and instructions for use of the final device.  The validation activities should demonstrate the complete product can be used successfully by the user, and should include usability validation as part of the validation activities.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 18-Feb-2019 19:59
From: Julie Omohundro
Subject: Design Validation

How do they determine whether the devices used in design validation were the initial production devices or their equivalent?  Just by asking?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 18-Feb-2019 17:01
From: Edwin Bills
Subject: Design Validation

While it is true that FDA does not review Design Validation using 510k reviews, they do ask about it during post-market inspections as is identified in the QSIT inspection guidance on page 33:It is also true that units from the PQ phase of Process Validation may be used as production equivalent units.  For any other choice, you must have a documented justification for the use of any other "prototypes" or "engineering builds".  The units used for Design Validation must be equivalent to those that a customer would get post-market.  Any changes that occurred after the "Design Validation" need to be validated prior to implementation of the changes under 820.30 (i).  So the question is, how much time will be saved if I try to do design validation before the production units are ready.  It is also true that Design Validation follows successful Design Verification, so if the design is not complete, you should not proceed to do Design Validation.  It is important to note that Design Validation includes packaging, labeling, and instructions for use.  so those too, must be complete.  Additionally, it does include human factors (or usability) validation.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 15-Feb-2019 07:21
From: James Bonds
Subject: Design Validation

Actually I have had FDA ask for justification, with supporting evidence, of my company's use of prototype units for a clinical study (e.g. design validation).  They were satisfied with our response, but it is important to be prepared to address the issue up front and not be caught unprepared.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Hi Gail,

Well, regulatory bodies might not be, but hopefully company or consulting QA or RA is tracing what was used to make the devices used for design verification or validation. Also, if anything is being sent for biocompatility testing, as Sponsor of the biocomp testing, you are responsible for characterization of that device ("test article") under the GLP regulations.

I did make a project team redo some  biocomp testing (thankfully it was an inexpensive  testing), because they did not have traceability of the components or pilot or final mfg process for the devic. But interestingly, the GLP lab never asked to see or get a statement that the article was characterized at all. I was unwilling to include those results in a submission.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Ginger,
I want to work with you! I wish everyone was like that, or allowed to be like that.
You're my hero :)

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States
------------------------------

Original Message:
Sent: 15-Feb-2019 07:50
From: Ginger Cantor
Subject: Design Validation

Hi Gail,

Well, regulatory bodies might not be, but hopefully company or consulting QA or RA is tracing what was used to make the devices used for design verification or validation. Also, if anything is being sent for biocompatility testing, as Sponsor of the biocomp testing, you are responsible for characterization of that device ("test article") under the GLP regulations.

I did make a project team redo some  biocomp testing (thankfully it was an inexpensive  testing), because they did not have traceability of the components or pilot or final mfg process for the devic. But interestingly, the GLP lab never asked to see or get a statement that the article was characterized at all. I was unwilling to include those results in a submission.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Thanks Gail,

I am sure pushback would have been more intense if it had been chronic tox that had to be redone!

The beauty now of being a consultant.  I give the same (good, practical) advice, but now I am the outside consultant who tells management what their internal poor beleaguered RA and QA people have been saying and trying to enforce forever.  

Love not having to deal with the politics EVERY single day. Just do good work.


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 15-Feb-2019 08:02
From: Gail Sauers
Subject: Design Validation

Ginger,
I want to work with you! I wish everyone was like that, or allowed to be like that.
You're my hero :)

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 15-Feb-2019 07:50
From: Ginger Cantor
Subject: Design Validation

Hi Gail,

Well, regulatory bodies might not be, but hopefully company or consulting QA or RA is tracing what was used to make the devices used for design verification or validation. Also, if anything is being sent for biocompatility testing, as Sponsor of the biocomp testing, you are responsible for characterization of that device ("test article") under the GLP regulations.

I did make a project team redo some  biocomp testing (thankfully it was an inexpensive  testing), because they did not have traceability of the components or pilot or final mfg process for the devic. But interestingly, the GLP lab never asked to see or get a statement that the article was characterized at all. I was unwilling to include those results in a submission.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Yes, but....if the regulatory bodies are not doing this trace, then, when you work your way through it, all the way to the very bottom, doesn't it mean that, in a very fundamental way, they don't actually know what it is they are regulating?​

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 15-Feb-2019 07:50
From: Ginger Cantor
Subject: Design Validation

Hi Gail,

Well, regulatory bodies might not be, but hopefully company or consulting QA or RA is tracing what was used to make the devices used for design verification or validation. Also, if anything is being sent for biocompatility testing, as Sponsor of the biocomp testing, you are responsible for characterization of that device ("test article") under the GLP regulations.

I did make a project team redo some  biocomp testing (thankfully it was an inexpensive  testing), because they did not have traceability of the components or pilot or final mfg process for the devic. But interestingly, the GLP lab never asked to see or get a statement that the article was characterized at all. I was unwilling to include those results in a submission.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 14-Feb-2019 09:25
From: Gail Sauers
Subject: Design Validation

All the information provided is great, but as Julie noted in another posting NO ONE is looking at the traceability of the product used for validation testing. At least no one from a regulatory body. This creates a dilemma for quality and regulatory folks who need that feedback to push the best actions within the organization.

------------------------------
Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States

Original Message:
Sent: 13-Feb-2019 18:17
From: Julie Omohundro
Subject: Design Validation

No, it doesn't have to, but it's a darn good idea. The earlier you validate (or verify), the more you risk chasing change after change after change before you can get it to the market.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

When you get to the design validation stage, you should be validating with at least a production unit that is representative of the final device.  Or a prototype that is close to the final device.  Yes, it would occur after a formal design transfer theoretically, but it doesn't have to. I would like to hear if others have different suggestions.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

As mentioned, theoretically Design Validation should occur after complete design transfer, but this often does not happen in the real world.  Julie is spot on that if you move design validation sooner in the process you run the risk of having to repeat testing or even the entire testing because of changes still occur prior to design transfer being complete.  I have created some graphics or visuals over the years that show basic "skewed distribution curves" which show development activities compared to manufacturing activities.  These curves then show "skewing" design verification versus design validation against a timeline of product development, but it is about the amount of risk the organisation wants to take by doing testing earlier or later.  Remember from the requirements: 'Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded' so should be representative samples so needs to be determined at what point in design transfer a representative sample can be tested.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Feb-2019 21:28
From: Karen Zhou
Subject: Design Validation

When you get to the design validation stage, you should be validating with at least a production unit that is representative of the final device.  Or a prototype that is close to the final device.  Yes, it would occur after a formal design transfer theoretically, but it doesn't have to. I would like to hear if others have different suggestions.

------------------------------
Karen Zhou

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Hi all,
as pointed out above design validation should be done on parts produced with the final production process, or production representative.  

And we can't have a production process until we start design transfer.  Therefore design validation should and I would say can not start prior to commencement of design transfer.

however certain design transfer and design validation  activities could be occurring in parallel. 

With respect to the sequence of when these activities finish.  I would say that the design validation finishes prior to the end of design transfer.  As for me the end of design transfer is the end of design process, where we go into production.    Some folks may argue the last point, but design transfer can not be fully signed off until we are sure everything is right.
hope that helps
seb



------------------------------
Sebastian Clerkin
Consultant
Ballincollig
Ireland
------------------------------

Original Message:
Sent: 13-Feb-2019 21:28
From: Karen Zhou
Subject: Design Validation

When you get to the design validation stage, you should be validating with at least a production unit that is representative of the final device.  Or a prototype that is close to the final device.  Yes, it would occur after a formal design transfer theoretically, but it doesn't have to. I would like to hear if others have different suggestions.

------------------------------
Karen Zhou

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

​I would say no.  The concept of validation of the design was placed prior to design transfer to capture the idea that only designs that have been verified and validated should be transferred to production.  Design Validation is a validation of the design, not the validation of the manufacturing to successfully and consistently reproduce the design in manufacturing.  This is part of the transfer process which is Process validation.

While it is true that there is some risk in validating a design before design transfer could require "revalidation" in as much as there could be changes that must be revalidated, particularly in those technologies where the manufacturing in plays a significant role in the quality of the device (which is not always the case), there is also the risk of transferring a design to manufacturing that has not ye been validated.  This could cause duplication of the transfer process after the making design changes necessary to validate the design if it fails after transfer.

Again, my answer would be NO, but the risks are more dependent on the potential impact of the process and not a regulatory requirement.

A final note, with regards to medical devices (perhaps not PMAs), submissions are most times made after design validation is completed , but before design transfer is completed.  Waiting for full transfer and validation of the process to perform validation before getting clearance would delay most programs.

Lee

------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

The answer is no, but if production units are not used for design validation a thorough justification must be provided that explains the differences between the units used for design validation and the final production units.  For example, if the difference is that there were no design changes and that the units were assembled by technicians using development level procedures as opposed to production workers using production released procedures, the gap between the units used and production units is not great.  On the other hand, if the results of a design validation resulted in any changes to the design (or indication or instructions for use), then an additional design validation would almost certainly be in order.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Agree with the above two posters: No

I don't think it's practical to have design transfer before design validation. What if you have to make changes to the design because there were issues in design validation? That would be a huge waste of company resources to go back, update everything, complete design transfer, and then execute design validation again.

The key is that product used for design validation is as close as possible to what is intended for manufacture. Any differences need to be evaluated for their impact on design validation, and may result in having to re-execute design validation.

------------------------------
Joshua Lust
Quality & Regulatory Affairs Manager
Grand Rapids MI
United States
------------------------------

Original Message:
Sent: 14-Feb-2019 06:42
From: James Bonds
Subject: Design Validation

The answer is no, but if production units are not used for design validation a thorough justification must be provided that explains the differences between the units used for design validation and the final production units.  For example, if the difference is that there were no design changes and that the units were assembled by technicians using development level procedures as opposed to production workers using production released procedures, the gap between the units used and production units is not great.  On the other hand, if the results of a design validation resulted in any changes to the design (or indication or instructions for use), then an additional design validation would almost certainly be in order.

James

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Thank you for all your feedback!

Regards,
Anjali Nair

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Hi Anjali, 

I agree with all No's.

I believe there is a misconception here.

Let's say:

You had an idea and designed a product. You have to decide which specifications you should have. At this point you look to your competitors and what are your customer's needs....

You need Design Verification. Design Verification you check your specifications. Were you able to make a product that meet specifications? for example, how big is your product, color, shape, and etc.... 

Then you need to validate the design. Design Validation you get the product you developed, with the specifications you were able to meet and test if it works in the real world. It is important to follow the instructions you created and etc.... for example, checking if you can make the cake with your "Super Cake Mix".

If your Design Verification and Validation proved that you have a good product you can submit for all regulatory approvals you want.

To start production you prepare a Design transfer, which is a document that will transfer the technology from development to production, doesn't matter if the production is in the same team, building, company or across the world. Because nobody in the manufacture should be digging through the DHF to find the information to manufacture something. The Design Transfer should tell everything that is important to know to manufacture the product.

Problem with small companies is that usually the same team that develops the product is the one that produces it. However, I advise that it is worth to organize your system in a way that Design Verification and Validation feeds Design Transfer. Design Transfer feeds Manufacture.

Once operations receive a design transfer it should prepare a process validation (some people refer to it as 3 batches validation).
 
Process Validation needs to be performed to proof that operations can manufacture the product consistently. For example, when you go to your favorite bakery everyday you like to buy your bread with the same color, smell, crunchiness, everyday.... if your bakery cannot offer the same bread everyday you don't go back there. 

So verification and validation of the design is one thing. Process validation is another thing. Design transfer should be in between. Of course they are all related, but the purpose of each one is different.

I hope I was able to add a little more to the discussion....

------------------------------
Cecilia Hutchins
Regulatory Affairs Liaison
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 14-Feb-2019 13:04
From: Anjali Nair
Subject: Design Validation

Thank you for all your feedback!

Regards,
Anjali Nair

------------------------------
Anjali Nair
Los Angeles, CA

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

​​What I can tell you is that when a VC-driven startup gets to the point of asking this question, it's burn rate is usually horrific, its investors are screaming, and it is often in immediate danger of running out of money if it doesn't hit its timelines and benchmarks.

So whatever it "should" or "should not" do, what it will do is validate whatever it has available to validate when it needs to validate it, to avoid going down in flames.  And yes, it will end up chasing changes later, but at least it will have a later in which to chase them, is how everyone is going to see it.  And there is really no reason it can't do that.  Nor, IMO, is there any reason it "shouldn't," if it is prepared to chase changes later.  Change control is going to have to kick in sooner or later; no reason it can't kick in now.

So when the question is framed as "must," I would say no, there is no "must" here.  Wise and not so wise, yes.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-Feb-2019 18:10
From: Anjali Nair
Subject: Design Validation

Hello everybody!

Is this true-
Design Validation must occur after design transfer to production specifications

Thanks

Regards,

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------