PSC Biotech™️ ensures that its equipment software validation is compliant with the GMP, GLP, ICH, EMA, 21 CFR Part 11 and other global regulations. Our approach is based on the industry standard GAMP 5 guidelines. PSC Biotech™️ places a strong emphasis on maintaining compliance and the validated status of the equipment by ensuring appropriate system specific management procedures and IT/quality management procedures are in place.

How We Stay Compliant

PSC Biotech™ ensures that its equipment software validation is compliant with the GMP, GLP, ICH, EMA, 21 CFR Part 11 and other global regulations. Our approach is based on the industry standard GAMP 5 guidelines. PSC Biotech™ places a strong emphasis on maintaining compliance and the validated status of the equipment by ensuring appropriate system specific management procedures and IT/quality management procedures are in place.

Why Choose PSC Biotech™?

PSC Biotech™ was conceived in 1996 with equipment and software validation in mind and has been closely associated with it ever since. PSC Biotech™ has experience in validating a huge variety of equipment from stand alone bench-top equipment through production scale manufacturing equipment. View a full list of software types here.

PSC Biotech™ has qualified and validated laboratory equipment all over the world and with many of its clients from start-ups through large multi-national Life Sciences companies.


Average Projected Timeline

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