As a member of the DI & IT Compliance Group, you will have here
possibiliy to access comments on draft guidances and working documents.
Concept Paper on the revision of Annex 11 (EMA/INS/GMP/778340/2022) - Comments
On 16 November 2022, EMA GMP/GDP Inspector Working Group and PIC/S published for comment the Concept Paper on the revision of Annex 11: Computerised Systems. This Concept Paper shall set scope and, in some extent, the level of detail of Annex 11 R2 and could be commented until 16 November 2023.
The ECA Foundation and its European QP Association set up an international Expert Working Group led by Yves Samson to submit extensive comments on the Concept Paper.
Submission of comments on Concept Paper on the revision of Annex 11 (EMA/INS/GMP/778340/2022) (January 2023)
Computer Software Assurance (CSA) for Production and Quality System Software - Comments
FDA GUIDANCE on Computer Software Assurance for Production and Quality System Software (September 2022) DRAFT FOR COMMENTS
Submission of comments by ECA Foundation / European QP Association (October 2022)
PICS PI 041 - Comments
Comparison of Draft 2 and 3 of the PIC/S Guidance on Data Integrity
Excel Sheet "ECA consolidated comments to PIC/S PI 041-1 on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments"
Excel Sheet "ECA consolidated comments to PIC/S PI 041-1 on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments"
WHO working document QAS/19.819 - Comments
WHO GUIDELINE ON DATA INTEGRITY (October 2019) DRAFT FOR COMMENTS
