Dear GLP Facilities,
As advised in our email of 24 September 2021, Document No 22 – Advisory Document of the Working Party on Good Laboratory Practice Document on GLP Data Integrity has been released. The implementation of this document will be included in the next reassessment of your facility as of 01 March 2022.
The document expands on many of the concepts that are already expressed in the Principles, in particular Document No 17 – Application of GLP Principles to Computerised Systems. It emphasises arisk-based approach to the management of data that includes data risk, criticality and life cycle. As stated in in the document:
TFM is expected to implement a fully documented system with supporting rationale that provides an acceptable state of control based on the data integrity risk.
It also provides guidance as to how this can be achieved. That is “perform a data integrity risk assessment where the processes that produce, process and/or store data are mapped out and each of the formats and their controls are identified and the data criticality, inherent risks and appropriate mitigations documented”.
If you have any question please contact your client coordinator. We also encourage you to provide feedback or send any queries you have to us to assist with the implementation of the document.