21 CFR Part 11 Frequently Asked Questions (FAQ) - METTLER TOLEDO
Know How

21 CFR Part 11 Frequently Asked Questions (FAQ)

Know How

Customer and supplier roles and responsibilities for assessment of METTLER TOLEDO STARe Software versions 18.00, 17.00, 16.40, 16.30, 16.20, 16.10, 16.00, 15.00, 14.00, 13.00, 12.10, 12.00 including 21 CFR 11 Compliance software option for compliance with the requirements of 21 CFR Part 11 regulations (Electronic Records and Electronic Signatures final rule) and European Union GMP Annex 11 and Chapter 4.

The purpose of this document is to outline the roles and responsibilities for 21 CFR 11 assessment and compliance and inform customers how METTLER TOLEDO is responding to the challenges presented by the regulation