Qualityze - Blogs

If you design, manufacture, or distribute medical devices, medical device compliance is the difference between accelerat...

AI can turn months of guesswork into days of clear answers—helping pharma and biotech teams bring better medicines to pa...

Every batch you produce carries a silent passport stamped by regulators, customers, and—most unforgiving of all—public t...

The typical data breach now costs USD 4.88 million and non-compliance runs 2.6 times pricier than doing the right thing,...

Beyond traditional specification testing, identifying patterns through Out of Trend (OOT) in Pharma provides an understa...

Every dose that reaches a pharmacy counter carries two invisible signatures: your company’s name and the promise of unco...

The modern business world more and more calls for a holistic and proactive approach to Health, Safety, and Environment (...

Getting FDA clearance or CE marking is just the opening act. True Software as a Medical Device (SaMD) excellence means a...

Quality inspection sits at the heart of any robust manufacturing or service operation. By systematically examining produ...

Did you know? Industry reports consistently highlight that the majority of FDA Form 483s are linked to noncompliance wit...

Environmental compliance may sound like paperwork but skipping it can sting. Regulators issued $1.7 billion in fines las...

The Quality Assurance Trends for 2025 are being shaped by executive mandates for operational efficiency, product stabili...