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© 2022 MJH Life Sciences and Spectroscopy Online. All rights reserved.
© 2022 MJH Life Sciences™ and Spectroscopy Online. All rights reserved.
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.
December 01, 2020
The calibration and qualification of analytical systems is a journey, not an event.
November 01, 2020
Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.
September 01, 2020
Spreadsheets are often used to perform GMP-related calculations, but can lead to serious problems and unnecessary risk. We explain why the use of spreadsheets is heavily discouraged in a regulated laboratory environment.
April 01, 2020
When using infrared (IR) instruments in a regulated laboratory, it is essential to conduct meaningful performance qualification (PQ) tests to maintain compliance.
December 01, 2019
The Food and Drug Administration (FDA) has issued an updated version of its Compliance Policy Guide for Pre-Approval Inspections (PAI). This article will guide you on this policy’s impact on analytical procedures and data included within regulatory submissions.