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© 2023 MJH Life Sciences and Spectroscopy Online. All rights reserved.
© 2023 MJH Life Sciences™ and Spectroscopy Online. All rights reserved.
September 01, 2023
The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in
pharmaceutical development. We explore how this could influence the PAI process now.
April 01, 2023
Now that the draft FDA guidance on computer software assurance (CSA) is out, we can see what it is—and is not.
September 01, 2022
A look at two ICH draft publications reveals that the EWG has much revision work to do for these publications to fully cover the validation lifecycle process.
April 01, 2022
It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.
December 01, 2021
We continue our explanation of the new PIC/S data guidance.
November 01, 2021
In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.
September 01, 2021
Computerized system validation (CSV) has an uninspiring reputation for
being a slow, no-value-added activity that only wastes time and delays the
implementation of new software. Is that an accurate portrayal? And is it a
April 01, 2021
“SneakerNet,” or the manual transfer of data using a disk or USB stick from one computer system to another, should be long dead, but this noncompliant transfer process still survives.
January 12, 2021