Data Integrity

esignatures-GxP-environment

E-Signatures on Documents in a GxP Environment – 7 Misconceptions

Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus …

good-documentation-practices-gdocp-v-gdp-pharma

Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP)
Good documentation practice (GDocP) is a crucial component of GMP compliance.

More frequently referred to as Good Recordkeeping Practice, good documentation practices are not only helpful during a regulatory inspection (GMP audit), non-conformance/deviation investigation, …

data measurements

MHRA: Data Integrity defined?

In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry.  As the name suggests, it is a glossary of DI terms where the definitions are further explained with …

Surprised man

US FDA continue to find Data Integrity violations

Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is to an API manufacturer who …