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 if there’s a loophole in one of the areas where a pharma company is behind? A small deviation or non-conformance could affect product quality greatly. CAPA in pharma provides a

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 highly regulated, and even if they were to implement the slightest change in their SOPs, machines, or any other aspect, it has to go through an arduous process. Change control

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 way to show that a computerized system works as intended, supported by documented evidence. But the way software gets built and delivered has changed. SaaS applications, cloud platforms, automation, and

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 just need to find a LIMS instance, an Excel macro, or a MES workflow that nobody can prove works as intended. That’s the gap computer system validation in pharma exists