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Blogs

Articles from our team on validation, qualification, monitoring and compliance.

All Environmental Monitoring Thermal Validation Clean Room Validation CSV & Data Integrity High-Tech Industries CQV Bio-Decontamination
Reading a particle counter calibration certificate (ISO 21501-4) Environmental Monitoring 13 Aug 20263 min read Reading a particle counter calibration certificate (ISO 21501-4) Counting efficiency, size resolution, false counts. The six numbers on the certificate that matter, and what good looks like. Read more Purified water system qualification: getting through the three phases CQV 6 Aug 20263 min read Purified water system qualification: getting through the three phases Two to four weeks, then two to four more, then a year. What each phase of a water PQ is really meant to prove. Read more Smoke studies: what an inspector looks for in your airflow video Clean Room Validation 30 Jul 20263 min read Smoke studies: what an inspector looks for in your airflow video A good airflow visualisation study is filmed like evidence, not like a demo. Planning, filming and the report. Read more Writing a URS your supplier can actually test against CSV & Data Integrity 23 Jul 20263 min read Writing a URS your supplier can actually test against Vague requirements make for vague tests. How to write user requirements that trace cleanly to the OQ. Read more
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