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© 2021 MJH Life Sciences and Chromatography Online. All rights reserved.
© 2021 MJH Life Sciences™ and Chromatography Online. All rights reserved.
Examination of audit trail entries is a key part of the second-person review. What do regulatory documents say about this topic, and how can we speed up review?
A look at the role of system suitability tests (SSTs) during performance qualification (PQ).
The author examines the process of validating a CDS and describes the trials along the way such as speed of validation, risk management, and so forth.