Dr. Schleuniger Pharmatron advanced documentation extends the standard documentation with detailed qualification and validation protocols that are accepted by regulatory authorities all over the world. All documents are continuously reviewed and extended to meet additional requirements.
Installation qualification (IQ)
All major components are tested, certified and
confirmed by the operator.
Operational qualification (OQ)
Documentation that the systems works flawlessly
within the limits specified.
Performance qualification (PQ)
Examination of product-relevant functions with your
tablets or test materials.
Computer system validation (CSV)
Software validation protocols to document software
functions and 21 CFR, Part 11 compliant operation.