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ChemStation CFR21 Pt 11 compliance

Discussions about chromatography data systems, LIMS, controllers, computer issues and related topics.

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Can ChemStation be CFR 21 Part 11 compliant without ChemStore?
OpenLab. Contact Agilent.

You need validated electronic security, that files and raw data cannot be monkeyed with or deleted. Good luck getting that to fly without the vendor's software.
No, ChemStation B version needs ChemStore/Security pack for compliance. OpenLAB ChemStation needs OpenLAB DataStore for compliance.
For single workstation compliance you better trade your ChemStation in for OpenLAB EZChrom, which is compliant from the ground up, stand-alone workstation to full blown client/server.
Freek Varossieau
OpenLab CDS 2 specialist
BeyondOpenLab
beyondopenlab@gmail.com
+5977114721
3 posts Page 1 of 1

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