Through the many different iterations of the CQV model, from the traditional V-model to the hybrid approach to the risk-based approach, a significant amount of time and effort has been spent demonstrating to regulatory inspectors…
What do you think high-performing pharmaceutical companies might be doing to perform better? You will observe that they are quick to identify and resolve issues.
This is NOT your usual article about data integrity. You should already know about the usual topics of ALCOA+, Data Lifecycle, Audit Trails and so
Before diving into the topic of paperless validation in the pharmaceutical industry, the fundamentals of Good Documentation Practice (GDP) shall be reiterated. Data integrity, arguably
The following information presented is based on the author’s interpretation and understanding of the EudraLex Volume 4 Annex 15 – Qualification and Validation, specifically on
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