Lab Instrument Qualification, the Easy Way
May 16 2023
The meaning of audit-ready is changing. Data integrity requirements are more rigorous and complex than ever before. Today, audits by regulatory authorities around the world, including the FDA, EMA and PDMA, are being conducted with increasing frequency and inspections in the laboratory are conducted much more thoroughly. The number of observations, including FDA 483 observations and warning letters, is increasing.
Anton Paar can help you be audit ready in just a single day. For the rotational viscometer ViscoQC 300, Anton Paar offers an instrument qualification package which goes significantly beyond simple installation and basic IQ/OQ, delivering a fully qualified analytical environment. A detailed risk analysis, performance qualification (PQ), traceability matrix, and final qualification report increase the value of the qualification package for the whole qualification process. Together with Anton Paar’s qualified installation support, this means you’ll reduce in-house personnel work by 60% to 70%.
ViscoQC 300 complies in standalone mode to 21 CFR Part 11, GMP and GAMP 5. Automate your data export, and kickstart your paperless lab with the lab execution software AP Connect. Just connect your instruments, communicate measurement information, and ensure full compliance.
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