Draft PIC/S guidance on data integrity

PIC/S has issued a new draft document relating to data integrity, titled “Good practices for data management and integrity in regulated GMP/GDP environments.” (PI 041-1 (Draft 2)).

According to the document:

Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. While the main focus of this document is in relation to data integrity expectations, the principles herein should also be considered in the wider context of good data management.

Data Integrity is defined as “the extent to which all data are complete, consistent and accurate, throughout the data lifecycle” and is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. Poor data integrity practices and vulnerabilities undermine the quality of records and evidence, and may ultimately undermine the quality of medicinal products.

Data integrity applies to all elements of the Quality Management System and the principles herein apply equally to data generated by electronic and paper-based systems.

The draft can be accessed here.


Posted by Dr. Tim Sandle