OZQA COMPANY

RESOURCES

Practical insights on Quality Management Systems, GxP compliance, Pharmacovigilance, and ISO-based quality systems for pharmaceutical and medical device companies.

OZQA featured in Science Report: Skills shortage is a growing bottleneck in life science

OZQA is featured in Science Report highlighting how lack of competencies, not regulation, is slowing the life science industry. Learn how to

Louise Søgaard Nielsen Joins OZQA as Pharmacovigilance Consultant in Europe

Louise Søgaard Nielsen joins OZQA as pharmacovigilance consultant, strengthening EU pharmacovigilance and GVP compliance support for biotech

If It’s Not Documented, It Didn’t Happen” – Especially When It Comes to Training

Why your team’s know-how doesn’t count unless you can prove it. You’ve hired smart people. Scientists with PhDs. Project managers with years of experience. People who actually read the SOPs (well, most of them). So you’d think your organisation is ready for inspection, right? Maybe. But let us ask you this: Can you prove that everyone has been trained on the latest version of the relevant SOPs? Can you show when they were trained? By whom? And on what? Can you demonstrate tha

Your CRO Is Great. But Regulators Don’t Know That

Why sponsors still need a rock-solid QMS – even when everything is outsourced You’ve found a great CRO. The budget’s signed, the project plan is aligned, and your team can finally breathe. Or so you thought. Here’s the hard truth: outsourcing doesn’t outsource responsibility. Not in the eyes of regulators. As a sponsor, you are still expected to know what’s happening — and have the documentation to prove it. CRO ≠ Compliance Let’s be clear: we love CROs. They’re operational l