Regulatory Open Forum

Dear RAPS team,

I hope you all are safe and healthy during these unusual circumstances. 

I have a question regarding the use of the "Adobe sign" feature for QMS document approvals.
Being a small size company, our QMS follows the traditional approval method(wet signatures). However, due to the current situation, most of us are working from home. Hence, we thought of using Adobe sign as an interim solution. I have revised our SOP for Document change control to reflect this change.
My question is , do we have to validate this software prior to use?

Looking forward to your valuable feedback.

Thanks!

Kind Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Hello,

Software should indeed be validated before use, especially towards FDA where part11 compliance should be checked.
For Adobe sign, there is a doc showing what should be done and what's covered by the tool

Part11Compliance


------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 07-Apr-2020 03:21
From: Soumya Rajesh
Subject: Validation - Adobe Sign

Dear RAPS team,

I hope you all are safe and healthy during these unusual circumstances.

I have a question regarding the use of the "Adobe sign" feature for QMS document approvals.
Being a small size company, our QMS follows the traditional approval method(wet signatures). However, due to the current situation, most of us are working from home. Hence, we thought of using Adobe sign as an interim solution. I have revised our SOP for Document change control to reflect this change.
My question is , do we have to validate this software prior to use?

Looking forward to your valuable feedback.

Thanks!

Kind Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Dear Franky Dubois,

Thanks a lot for the document! very much appreciated! It is indeed very helpful.

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Original Message:
Sent: 08-Apr-2020 02:30
From: Franky Dubois
Subject: Validation - Adobe Sign

Hello,

Software should indeed be validated before use, especially towards FDA where part11 compliance should be checked.
For Adobe sign, there is a doc showing what should be done and what's covered by the tool

Part11Compliance


------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 07-Apr-2020 03:21
From: Soumya Rajesh
Subject: Validation - Adobe Sign

Dear RAPS team,

I hope you all are safe and healthy during these unusual circumstances.

I have a question regarding the use of the "Adobe sign" feature for QMS document approvals.
Being a small size company, our QMS follows the traditional approval method(wet signatures). However, due to the current situation, most of us are working from home. Hence, we thought of using Adobe sign as an interim solution. I have revised our SOP for Document change control to reflect this change.
My question is , do we have to validate this software prior to use?

Looking forward to your valuable feedback.

Thanks!

Kind Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------