David Churchward

Expert GMP Inspector

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Chemist wearing safety glasses and using a tablet

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures.  Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.

MHRA data integrity guidance: 18 months on

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments”

Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

Vials in a laboratory

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 2

Data charts on a screen

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …