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ICH Q7 is the globally harmonized Good Manufacturing Practice (GMP) guideline for Active Pharmaceutical Ingredients (API...

Manufacturing generates massive amounts of operational data each minute — machine sensors, inspection cameras, operator ...

When companies consider "quality," it's usually in the context of compliance, inspections, or customer demands. But in t...

This blog is a simple guide that breaks down these two powerful concepts in straightforward terms, showing how pharma co...

When you hear the word quality, what do you think of? Maybe a perfect product that works exactly as you expected, compri...

We believe version control is the quiet backbone of quality—when everyone works from the right version, everything else ...

Each organization, however well-established its processes are, is faced with times when things don't go just the way one...

A clear, no-nonsense guide to OSHA’s injury and illness trio—Form 301 (the incident story), Form 300 (the running log), ...

Regulatory affairs (RA) is the discipline that gets safe, effective medical devices to patients—legally. It connects pro...

In healthcare, quality is not something we want in addition—it's the essence of safe, effective, and compassionate care....

Quality comes at a cost, whether companies are aware of it or not. Each choice—from training staff to dealing with a cus...

Improving processes, of course, is all about fixing what isn't right. But identifying what's not right isn't always the ...