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ChemStation CFR21 Pt 11 compliance

Posted: Sat Jun 22, 2013 8:00 pm
by Joe90
Can ChemStation be CFR 21 Part 11 compliant without ChemStore?

Re: ChemStation CFR21 Pt 11 compliance

Posted: Mon Jun 24, 2013 10:32 pm
by Consumer Products Guy
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.

Re: ChemStation CFR21 Pt 11 compliance

Posted: Tue Jun 25, 2013 7:32 am
by varossf
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.