Data Integrity

In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity.

Different authorities have published draft guidelines:

In April 2016, the FDA issued a first draft Guidance for Industry, “New FDA Draft Guidance Data Integrity and Compliance with cGMP”

In July 2016, the MHRA issued a third draft, ” MHRA GxP Data Integrity Definitions and Guidance for Industry – Draft version for consultation”.

In August 2016, the PIC/S issued a first draft “Good Practices for Data Management and Integrity in regulated GMP/GDP environments”.

Simultaneously the EMA extended their web side Questions and answers in “Good Manufacturing Practices” by 23 answers on Data Integrity questions.

GxP-Pharma Support AS recommends these guidelines and Q&A’s when assessing the company compliance level of Data Integrity.

Lone Cleveland Andersen
GxP-Pharma Support A/S