Qualityze - Blogs

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

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

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

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

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

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

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

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

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

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

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