Insights from the QIS field team.
Practical writing on CSV, CQV, Annex 1 engineering, data integrity and training — from consultants who spend their days on the shop floor.
Krishna Deepak
The pharma industry is moving faster than ever. Medicines are manufactured, rigorously tested, and dispatched through a carefully curated process that’s followed diligently. But what
Krishna Deepak
Change is a continuous process. When millions of lives depend on it, it has to be assessed and evaluated with intensive care. Pharmaceutical companies are
Krishna Deepak
CSV vs CSA: Key Differences, FDA Guidance and Risk-Based Validation Approach Most regulated organizations already know Computer System Validation well. It has been the standard
Krishna Deepak
A single unvalidated system is often all it takes to earn your site a Form 483. Inspectors don’t need to find a bad batch; they