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 some context to aid in applying the existing regulations available. This is an update to their…
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 acknowledged to the inspector during the inspection that a laboratory analyst substituted a reference…
Data Integrity Violations Data Integrity violations or data errors can happen in 3 ways: fat finger errors (an accidental lapse by an operator), falsification (a rogue operator who enters false results) and fraud (collusion by a number of people). In this blog post, we’ll investigate how to reduce the risk of all three. With…
The review of data is the basis of everything that we do in the industry. It is the foundation of regulatory filings, controls in manufacturing, the checks in laboratory analysis, assurance of product release and so on. We continue to discuss DI issues as they continue to appear in US FDA Warning Letters, EU non-compliance…
Pharmaceutical Cloud Computing As we evaluate pharmaceutical cloud computing as an option we see pharma companies are slow to adopt cloud computing services, mainly because of the perceived data security / data integrity risk and fear of regulatory interpretations. I frequently hear, “How do you validate the cloud?” or “What will the regulator say?”, but most…
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