PIC/S Draft Guidance on Data Integrity

On 30-Nov-2018 PIC/S published the third draft of guidance PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments“. The first draft was published back in 2016, and the third draft is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft is applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period (3 months).

In short, you can expect inspectors to have reviewed and be reviewing against this. Do your gap analysis now and have plans in place to address the gaps. Yes, there will be a little while before this is finally published, but at this point this guidance neatly triangulates with other guidances on data integrity and we can expect most of this to be in the final version.

This document is a great place to start and can be used to develop whole sections of the quality management system. I find it very actionable. For example this table from 9.5 “Data capture/entry for computerised systems”:

pics data capture part 1pics data capture part 2



4 thoughts on “PIC/S Draft Guidance on Data Integrity

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