Regulatory Open Forum

Hi colleagues 
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

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Desmond Chng
Singapore
Singapore
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This is a tricky question, because while this is how current technology is applied, and some would argue "state of the art", there is still much layover by auditors/inspectors to have the actual hard copy record still available.  One way to make sure that these electronic records are acceptable is first have your electronic system clearly defined, validated, back-up process, maintenance, and "prevention of deterioration" of quality records.  There are many activities that must be implemented to make sure that your electronic records are maintained as the original would be kept.

The second aspect is to verify this process for converting hard copy to electronic version only.  This means that once you convert the hard copy to an electronic record and dispose of the original, there is a process in place to verify that the electronic version is proper, correct, and accurate from the original.  This can be done a number of ways such as one is to have a verification by a second person once the hard copy is scanned that it is a true copy and verifies on a log or something similar.

With a final note, if you are following ISO 13485:2016 use a risk-based approach to this process to apply proper controls for making sure the electronic version is properly controlled and maintained.  Read through the validation of QMS systems, Section 4.2.6, to apply the type of risk-based approach to these processes as well.  With that said, still use caution because some auditors/inspectors are not fully convinced or more precisely may not fully accept an electronic only version of a record.  Good luck !

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 03-Feb-2018 00:33
From: Desmond Chng
Subject: Electronic records

Hi colleagues
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

It is not necessary to save hard copy records if the scanned copies are stored in a secure manner in a Part 11 compliant system.  Some have argued that the document should be "certified" as a true copy, but that is probably not necessary.  Even better yet is to create the document electronically in the first place and obtain electronic signatures.

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Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 03-Feb-2018 00:33
From: Desmond Chng
Subject: Electronic records

Hi colleagues
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

​Thank You, guys.
I will take your comments and look into implementation of the softcopy.

Regards
Desmond

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

Original Message:
Sent: 05-Feb-2018 07:24
From: Glen Park
Subject: Electronic records

It is not necessary to save hard copy records if the scanned copies are stored in a secure manner in a Part 11 compliant system.  Some have argued that the document should be "certified" as a true copy, but that is probably not necessary.  Even better yet is to create the document electronically in the first place and obtain electronic signatures.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 03-Feb-2018 00:33
From: Desmond Chng
Subject: Electronic records

Hi colleagues
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

Latest regulatory draft guidance on Data Integrity from MHRA indicates that it is OK to destroy the paper if you have confirmed it as a true copy, which includes documentation that verification of true copy has been done.  

MHRA GxP Data Integrity Definitions and Guidance 2 for Industry (Draft for consultation - 2016)
Original records and true copies must preserve the integrity (accuracy, completeness, content and meaning) of the record. True copies of original records may be retained in place of the original record (e.g. scan of a paper record), provided that a documented system is in place to verify and record the integrity of the copy. Companies should consider any risk associated with the destruction of original records.

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Kevin Wojtas
Global Head, Computer Systems Quality
Takeda Pharmaceuticals
Cambridge MA
United States
------------------------------

Original Message:
Sent: 06-Feb-2018 03:50
From: Desmond Chng
Subject: Electronic records

​Thank You, guys.
I will take your comments and look into implementation of the softcopy.

Regards
Desmond

------------------------------
Desmond Chng
Singapore
Singapore

Original Message:
Sent: 05-Feb-2018 07:24
From: Glen Park
Subject: Electronic records

It is not necessary to save hard copy records if the scanned copies are stored in a secure manner in a Part 11 compliant system.  Some have argued that the document should be "certified" as a true copy, but that is probably not necessary.  Even better yet is to create the document electronically in the first place and obtain electronic signatures.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 03-Feb-2018 00:33
From: Desmond Chng
Subject: Electronic records

Hi colleagues
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

​Thank You Kevin

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------

Original Message:
Sent: 06-Feb-2018 11:50
From: Kevin Wojtas
Subject: Electronic records

Latest regulatory draft guidance on Data Integrity from MHRA indicates that it is OK to destroy the paper if you have confirmed it as a true copy, which includes documentation that verification of true copy has been done.

MHRA GxP Data Integrity Definitions and Guidance 2 for Industry (Draft for consultation - 2016)
Original records and true copies must preserve the integrity (accuracy, completeness, content and meaning) of the record. True copies of original records may be retained in place of the original record (e.g. scan of a paper record), provided that a documented system is in place to verify and record the integrity of the copy. Companies should consider any risk associated with the destruction of original records.

------------------------------
Kevin Wojtas
Global Head, Computer Systems Quality
Takeda Pharmaceuticals
Cambridge MA
United States

Original Message:
Sent: 06-Feb-2018 03:50
From: Desmond Chng
Subject: Electronic records

​Thank You, guys.
I will take your comments and look into implementation of the softcopy.

Regards
Desmond

------------------------------
Desmond Chng
Singapore
Singapore

Original Message:
Sent: 05-Feb-2018 07:24
From: Glen Park
Subject: Electronic records

It is not necessary to save hard copy records if the scanned copies are stored in a secure manner in a Part 11 compliant system.  Some have argued that the document should be "certified" as a true copy, but that is probably not necessary.  Even better yet is to create the document electronically in the first place and obtain electronic signatures.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 03-Feb-2018 00:33
From: Desmond Chng
Subject: Electronic records

Hi colleagues
Do we need to keep hardcopy of training records if we have scanned it into system. Can we just print it out as and when the inspectors need to checked on the training?

Thank you

Regards

------------------------------
Desmond Chng
Singapore
Singapore
------------------------------