Tuesday, 15 June 2021 15.30 - 17.00 h
In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" (see also Data Integrity - two new documents from PIC/S and EMA).
Chapter 5 provides a description of what a "Data Governance" system means for authorities and what requirements result from it for pharmaceutical companies.
"Data Governance" means the sum of all measures taken to assure data integrity. This should guarantee that data are handled completely, consistently and accurately over the whole data lifecycle - beginning from their creation up to their deletion.
The data governance system should be integrated into the pharmaceutical quality management system.
This also includes the determination of data ownership. Both organisational and technical controlling measures are proposed.
The organisational controls include:
It is expected that the periodic reviews are performed as part of self-inspections (as internal audits). But they can also be executed in any other way as periodic monitoring of the processes.
The periodic reviews should ensure that data controls work as intended.
To access the complete PIC/S document please see "Draft PIC/S Good Practices for Data Management and the Integrity in Regulated GMP/GDP Environments" in the PIC/S publications.