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What is a Job Safety Analysis (JSA) and Why Is It Important

Organizations with a mature safety culture understand that Job Safety Analysis (JSA) is not just a documentati...

Intended Use and Indications of Use: What You Need to Know

One poorly chosen verb in a product label can land you into an FDA “refuse-to-accept” letter, a re-run of clin...

ICH E6 R3 Good Clinical Practice (GCP): What You Need to Know

ICH E6 R3 demands that critical-to-quality risks, digital data flows, and consent clarity are baked in — not p...

What is Design Verification & Validation: The Ultimate Guide

For medical device, pharma, or biotech companies, product design is not an engineering exercise, but a complia...

Supplier Corrective Action Request: What You Need to Know

Have you ever received a faulty component from a supplier and wondered how to fix and prevent it from happenin...

Most Important Quality Metrics in a Pharmaceutical QMS

Under comprehensive GMP regulations, only a well-built QMS can assure consistent drug safety and quality. Thin...

510k vs PMA Medical Device Approvals: What You Need to Know

Have you ever used a medical device? If you are an adult, chances are high that you must have used one, whethe...

How to Prevent Non-conformances in Quality Management

How much does preventing quality failures truly matter? It matters immensely. Preventing non-conformances in q...

What Is IEC 62304: It’s Important in Med Device Compliance

IEC 62304 is an international standard that defines the life cycle requirements for medical device software. I...

How to Write an Effective Quality Investigation Report

A quality investigation report is a formal document that narrates the step-by-step inquiry into a specific qua...

Important Guidelines for Investigation in Pharma Industry

In the pharmaceutical industry, even minor anomalies aren’t just warning signs—they become immediate triggers ...

FDA Class 3 Medical Device: All You Need to Know

When it comes to medical devices, not all risks are created equal. Class III devices sit at the top of the ris...

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