Insights
Writing from the regulated delivery floor
Practical notes on validation, design controls and the parts of regulated engineering that documentation templates never explain.
7 min read
Traceability without spreadsheets
A requirements traceability matrix maintained by hand is already out of date. We generate ours from the tools the team already uses.
Dana Yerzhanova · Quality management representative
9 min read
Reading IEC 62304 safety classification honestly
Safety class follows from the harm a failure can cause. Teams read it as a measure of complexity and pay for that at submission.
Marat Iskakov · Engineering principal, health practice
8 min read
Validating a CI pipeline in a GxP environment
Unvalidated automation is the compliance risk. A qualified pipeline carries more evidence than any manual process ever did.
Aliya Sultanova · Validation lead, life sciences practice
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