Data Integrity

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Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP)
Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances.

Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to …

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 …