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How to Conduct a Management Review Under ISO 13485 Section 5.6
Management review is one of the most frequently mishandled requirements in ISO 13485. Companies hold meetings, check the box, and
How to Set Up Document Control in a Regulated Environment
When an FDA investigator walks into your facility, the first thing many of them ask for is your document control
How to Write a Design History File That Passes FDA Review
The Design History File (DHF) is the documentary record of the entire design and development process for a medical device.
How to Validate Computer Systems Under FDA’s CSA Guidance
For decades, pharmaceutical and medical device companies validated computer systems using a documentation-heavy approach rooted in traditional IQ/OQ/PQ protocols. For
How to Build an Audit-Ready QMS That Maintains Readiness Every Day
Most pharmaceutical and medical device companies treat audit readiness as a project. In the weeks before an FDA inspection or
How to Calculate and Reduce the Cost of Poor Quality (COPQ)
The cost of poor quality (COPQ) is what organizations spend because things go wrong. It covers scrap, rework, product recalls,