Regulatory Open Forum

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Hej Richard,

Thank you for your reply!

Fully agree with the TD including references to the design, development and manufacturing documents.
I was mainly considering the need to perform the regression testing on minor software changes but you did answer to that when saying that this is presented as part of major revisions.

Thank you for this useful input!

BR,
George

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------



Original Message:
Sent: 10-Dec-2022
From: Richard Vincins
Subject: RE: 'SaMD Technical Documentation'

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Regression tests need to be done continuously in every build released where results of current version shall be compared with previous results to detect the unintended effects of software change or modification. t is also important to detect any defects introduced by software changes early, as the cost to fix a defect later in a development cycle is much more expensive. This regression testing is the mitigation and tracking approach to identify defects in software in development and is almost needs to maintained and added to when new functionality is added to the software in program lifecycle.

------------------------------
Seema Singh
Regulatory Affairs & CMC
Tokyo
Japan
------------------------------

Original Message:
Sent: 10-Dec-2022 08:20
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hej Richard,

Thank you for your reply!

Fully agree with the TD including references to the design, development and manufacturing documents.
I was mainly considering the need to perform the regression testing on minor software changes but you did answer to that when saying that this is presented as part of major revisions.

Thank you for this useful input!

BR,
George

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden

Original Message:
Sent: 10-Dec-2022
From: Richard Vincins
Subject: RE: 'SaMD Technical Documentation'

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Thank you for sharing this information Seema.

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------



Original Message:
Sent: 11-Dec-2022
From: Seema Singh
Subject: RE: 'SaMD Technical Documentation'

Regression tests need to be done continuously in every build released where results of current version shall be compared with previous results to detect the unintended effects of software change or modification. t is also important to detect any defects introduced by software changes early, as the cost to fix a defect later in a development cycle is much more expensive. This regression testing is the mitigation and tracking approach to identify defects in software in development and is almost needs to maintained and added to when new functionality is added to the software in program lifecycle.

------------------------------
Seema Singh
Regulatory Affairs & CMC
Tokyo
Japan
------------------------------

Original Message:
Sent: 10-Dec-2022 08:20
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hej Richard,

Thank you for your reply!

Fully agree with the TD including references to the design, development and manufacturing documents.
I was mainly considering the need to perform the regression testing on minor software changes but you did answer to that when saying that this is presented as part of major revisions.

Thank you for this useful input!

BR,
George

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden

Original Message:
Sent: 10-Dec-2022
From: Richard Vincins
Subject: RE: 'SaMD Technical Documentation'

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Original Message:
Sent: 12/10/2022 7:24:00 AM
From: Richard Vincins
Subject: RE: 'SaMD Technical Documentation'

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------

Hello Atul,

As Seema indicated each version should have testing performed and documented.  If a company is using a more Agile type of software development, this indeed can be quite challenging.  It is probably too much too detail to contribute in a forum post, but there are ways this documentation can be generated for short cycle software development.  Without seeing the software, your development process, the testing activities, and how your Design Record is structured it would also be difficult to provide any further advice.  You might look at the guidance AAMI TIR45 or some white papers companies have published how documentation can be generated for frequent software updates.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Dec-2022 00:56
From: Atul Deo
Subject: 'SaMD Technical Documentation'

Hi Richard,

I have a follow up question on this topic. With frequent software updates ( eg- release every 2,4 weeks), it is very hard and time consuming to keep with the update of DHF index for the product. Is it sufficient to just have the final release engineering change note number or similar for that release( which can point to other reference docs) or does it have to detailed information in the DHF index. Project plans...requirements..test plans.. reports....ect. thank you in advance!!

Cheers 

Atul

Original Message:
Sent: 12/10/2022 7:24:00 AM
From: Richard Vincins
Subject: RE: 'SaMD Technical Documentation'

Hiya George,

There can be quite different interpretations to your question about regression testing and more variation on how this is presented in the Technical Documentation.  There is not a "right" way in how regression testing may be performed and shown in the technical documentation for minor versions.  Typically this is presented as part of major revisions.  What to remember is Technical Documentation encompasses all design, development. and manufacturing, so the file should be more of an index pointing to where information is located.  Therefore, the regression testing done for any versions should be in a tally, table, or structured in a way which can be reviewed.  Then in the Technical Documentation file there is a reference or summary for this information.  It might be a little difficult to describe because there are multiple ways this could be done for the Technical Documentation.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:09
From: George Magkaniotis
Subject: 'SaMD Technical Documentation'

Hello,

I have a query related to the Technical Documentation for SaMD.

Regression testing is part of the TD and that is performed before a version/build is released and distributed to Customers.
Is it mandatory to perform that test in the intermediate versions if those are not going to be used by a Customer?
For example: the regression testing has been done on v2.1.2 till v2.1.4. We continue to have a few intermediate builds like 2.1.5 and 2.1.6 and then decide to have a final version of 2.1.7 which will be released and distributed. Do we need to have the regression testing results for the intermediate versions in our technical documentation or is it enough with omitting those and have 2.7 documented directly after 2.1.4?

Thank you in advance for your time reading my query!

---------------------------------
George Magkaniotis MSc, BSc
QA/RA Associate

Tyresö
Sweden
---------------------------------