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The upcoming revision of ISO 9001, slated for release in late 2026, was recently released internally to ISO member bodies;...
We often hear about issues that our customers faced with their previous systems. We’ve gathered some of the common issues...
Many of our customers ran into challenges with their legacy systems. To help, we’ve outlined some of the most common...
At PSC Software, we often hear about issues that our customers faced with their legacy systems. We’ve gathered some of...
The EU AI Act is poised to reshape the landscape of artificial intelligence, particularly impacting highly regulated sectors. Understanding and...
This article explores the key differences between CSV and the new CSA, the FDA’s guidance, and how organizations can adopt...
GAMP 5 Second Edition marks the next step in guidance for computerized systems validation within the pharmaceutical industry. This updated...
Augmented Reality (AR) and Virtual Reality (VR) are revolutionizing various industries, and the life sciences sector is no exception. These...
This whitepaper is the final part of a two-part series on the use of AI in regulated industries. It explores...
Digital twin technology is emerging as a transformative force in the evolving field of pharma and biopharma manufacturing. This article...
In the life sciences, data is the bedrock of patient safety, product quality, and regulatory compliance. Every piece of information,...
AI is reshaping quality management, but in life sciences and other regulated industries it must be proven to be reliable....
A robust Corrective and Preventive Action (CAPA) process is more than just a regulatory checkbox; it’s the engine of continuous...
Startups in high-growth or regulated industries often face unique challenges in managing assets and quality. Relying on spreadsheets or informal...
Selecting the best Quality Management System (QMS) software can feel overwhelming. It’s a crowded market with dozens of options, each...
In the highly regulated world of life sciences-from pharmaceuticals and medical devices to biotechnology-training compliance is non-negotiable. Adherence to GxP...
Implementing a modern Quality Management System (QMS) is a crucial step for organizations aiming to improve compliance, streamline quality processes,...
On May 6th, 2025, the FDA released a news release titled “FDA Announces Expanded Use of Unannounced Inspections at Foreign...
