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Process Analytical Technologies (PAT)

 

Advances in automated performance verification for UV/VIS spectrophotometers

22 August 2018 | By Mettler-Toledo

Regulated environments require performance verification (qualification) of UV/VIS spectrophotometers on a regular basis. Instrument performance is the main factor directly affecting the accuracy and repeatability of measurements. Hence, it is important that this is regularly monitored and that documentary evidence is provided. Optical performance verification is conducted to the widely…

Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…