Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

As more companies outsource manufacturing and testing activities.  Most CMO's provide a handwritten signature designating they have reviewed and approved the record in a pdf.    Currently, the organization I work for will provide a handwritten signature for approval in return.  Then move the file into our eDMS to attest the record is the full complete record.   We do not maintain paper records.

We have recently validated an electronic signature platform (Docusign) that we would prefer to start using for all documents.   A debate has been raised if we can receive in a scanned handwritten signature file from our vendor and then proceed to provide our approval in an electronic format.  Then we move the file into our eDMS as the final repository.

In reading Part 11 I see few opportunities for interpretation.   The guidance continues to refer to the predicate rule requirements.   What are the predicate rule requirements.  I am curious how others would interpret the guidance. 

I have inserted a few statements from Part 11 below that have me questioning if it is acceptable.

Any thoughts from participants is appreciated.

"11.1 (b), However, this part does not apply to paper records that are, or have been, transmitted by electronic means."

"11.1 (c), Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signature to be equivalent to full handwritten signature, initials, and other general signings as required by agency regulations..."

"11.2 (a), ...persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part,..."

"11.70, Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means."

"B. Details of Approach - Scope of Part 11, 2., "Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities.  We recommend that you document this decision."

First, FDA uses the term "predicate rules" to refer to any regulation that requires a signed document to record GXP information (at that is the simple way I think about it). Second, the citations you provide about Part 11 not referring to documents with a manual signature I think did not anticipate that a document could have both manual and electronic signatures. Our practice is to allow both manual and electronic signatures.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 11-Mar-2019 14:44
From: Anonymous Member
Subject: Part 11 Electronic Signature Interpretation

This message was posted by a user wishing to remain anonymous

As more companies outsource manufacturing and testing activities.  Most CMO's provide a handwritten signature designating they have reviewed and approved the record in a pdf.    Currently, the organization I work for will provide a handwritten signature for approval in return.  Then move the file into our eDMS to attest the record is the full complete record.   We do not maintain paper records.

We have recently validated an electronic signature platform (Docusign) that we would prefer to start using for all documents.   A debate has been raised if we can receive in a scanned handwritten signature file from our vendor and then proceed to provide our approval in an electronic format.  Then we move the file into our eDMS as the final repository.

In reading Part 11 I see few opportunities for interpretation.   The guidance continues to refer to the predicate rule requirements.   What are the predicate rule requirements.  I am curious how others would interpret the guidance.

I have inserted a few statements from Part 11 below that have me questioning if it is acceptable.

Any thoughts from participants is appreciated.

"11.1 (b), However, this part does not apply to paper records that are, or have been, transmitted by electronic means."

"11.1 (c), Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signature to be equivalent to full handwritten signature, initials, and other general signings as required by agency regulations..."

"11.2 (a), ...persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part,..."

"11.70, Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means."

"B. Details of Approach - Scope of Part 11, 2., "Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities.  We recommend that you document this decision."

​ Hello I am new to this forum. Glen has responded to the predicate rule requirements. So this response is about the debate that you are having. I think 11.1 (b) answers your question/debate. Signing an already signed document does not give much information. We use our internal review form to assess and approve external documents  to establish equivalency with our internal documents and attach or reference the external documents. Hope this helps.

------------------------------
Kasi Gurung
Germantown TN
United States
------------------------------

Original Message:
Sent: 12-Mar-2019 08:50
From: Glen Park
Subject: Part 11 Electronic Signature Interpretation

First, FDA uses the term "predicate rules" to refer to any regulation that requires a signed document to record GXP information (at that is the simple way I think about it). Second, the citations you provide about Part 11 not referring to documents with a manual signature I think did not anticipate that a document could have both manual and electronic signatures. Our practice is to allow both manual and electronic signatures.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 11-Mar-2019 14:44
From: Anonymous Member
Subject: Part 11 Electronic Signature Interpretation

This message was posted by a user wishing to remain anonymous

As more companies outsource manufacturing and testing activities.  Most CMO's provide a handwritten signature designating they have reviewed and approved the record in a pdf.    Currently, the organization I work for will provide a handwritten signature for approval in return.  Then move the file into our eDMS to attest the record is the full complete record.   We do not maintain paper records.

We have recently validated an electronic signature platform (Docusign) that we would prefer to start using for all documents.   A debate has been raised if we can receive in a scanned handwritten signature file from our vendor and then proceed to provide our approval in an electronic format.  Then we move the file into our eDMS as the final repository.

In reading Part 11 I see few opportunities for interpretation.   The guidance continues to refer to the predicate rule requirements.   What are the predicate rule requirements.  I am curious how others would interpret the guidance.

I have inserted a few statements from Part 11 below that have me questioning if it is acceptable.

Any thoughts from participants is appreciated.

"11.1 (b), However, this part does not apply to paper records that are, or have been, transmitted by electronic means."

"11.1 (c), Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signature to be equivalent to full handwritten signature, initials, and other general signings as required by agency regulations..."

"11.2 (a), ...persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part,..."

"11.70, Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means."

"B. Details of Approach - Scope of Part 11, 2., "Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities.  We recommend that you document this decision."

Infect, electronic record system (eDMS) has 2 clear objectives:
1. Approval of the internal documents, using the validated system
2. Archiving the external document (manually signed) in the system, in linkage with the relevant activity / project. 

In both cases, an approval cycle is followed to ensure the integrity of internal and external document going in the validated e-system

------------------------------
Rajnish Kumar
Founder
Delft
Netherlands
------------------------------

Original Message:
Sent: 14-Mar-2019 15:21
From: Kasi Gurung
Subject: Part 11 Electronic Signature Interpretation

​ Hello I am new to this forum. Glen has responded to the predicate rule requirements. So this response is about the debate that you are having. I think 11.1 (b) answers your question/debate. Signing an already signed document does not give much information. We use our internal review form to assess and approve external documents  to establish equivalency with our internal documents and attach or reference the external documents. Hope this helps.

------------------------------
Kasi Gurung
Germantown TN
United States

Original Message:
Sent: 12-Mar-2019 08:50
From: Glen Park
Subject: Part 11 Electronic Signature Interpretation

First, FDA uses the term "predicate rules" to refer to any regulation that requires a signed document to record GXP information (at that is the simple way I think about it). Second, the citations you provide about Part 11 not referring to documents with a manual signature I think did not anticipate that a document could have both manual and electronic signatures. Our practice is to allow both manual and electronic signatures.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 11-Mar-2019 14:44
From: Anonymous Member
Subject: Part 11 Electronic Signature Interpretation

This message was posted by a user wishing to remain anonymous

As more companies outsource manufacturing and testing activities.  Most CMO's provide a handwritten signature designating they have reviewed and approved the record in a pdf.    Currently, the organization I work for will provide a handwritten signature for approval in return.  Then move the file into our eDMS to attest the record is the full complete record.   We do not maintain paper records.

We have recently validated an electronic signature platform (Docusign) that we would prefer to start using for all documents.   A debate has been raised if we can receive in a scanned handwritten signature file from our vendor and then proceed to provide our approval in an electronic format.  Then we move the file into our eDMS as the final repository.

In reading Part 11 I see few opportunities for interpretation.   The guidance continues to refer to the predicate rule requirements.   What are the predicate rule requirements.  I am curious how others would interpret the guidance.

I have inserted a few statements from Part 11 below that have me questioning if it is acceptable.

Any thoughts from participants is appreciated.

"11.1 (b), However, this part does not apply to paper records that are, or have been, transmitted by electronic means."

"11.1 (c), Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signature to be equivalent to full handwritten signature, initials, and other general signings as required by agency regulations..."

"11.2 (a), ...persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part,..."

"11.70, Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means."

"B. Details of Approach - Scope of Part 11, 2., "Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities.  We recommend that you document this decision."