Resource Library

For decades, Corrective and Preventive Action (CAPA) has held a contentious position in the life sciences industry. Ask any Quality Director about their relationship with CAPA, and you will...

For decades, Post-Market Surveillance (PMS) has been the "eat your vegetables" portion of the life sciences lifecycle. It was necessary, mandated, and often begrudgingly executed by Quality...

A Non-Conformance Report (NCR) is the "check engine light" of your operation, a signal that something has deviated from the standard, requiring investigation and correction.

For many startup founders and biotech executives, "compliance" conjures images of endless paperwork, fragmented spreadsheets, slowed innovation, and ballooning costs.

It is a story as old as the life sciences industry itself.

In the modern life sciences ecosystem, the concept of the "vertically integrated" pharmaceutical company is largely a relic of the past.

In the medical device industry, regulatory stability is the norm. The rules change slowly, often over decades. But every once in a while, a seismic shift occurs that forces every...

ISO 9001 gets a lot of airtime in quality circles, but for life sciences teams juggling FDA expectations, clinical milestones, and shifting regulatory frameworks, it can be hard to pin down...

What is cGMP in Pharmaceuticals?

Document control is the backbone of product quality, data integrity, and patient safety. Every SOP, batch record, and validation report represents a promise to regulators and patients that...

In life sciences, trust defines success. Patients, regulators, and partners rely on companies to develop safe and effective products with complete transparency.