FDA/CFR 21 Part 11
The 21 CFR part 11 rule provides requirements under which the Food and Drug Administration (FDA) of America will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures
Workbench and FDA / 21 CFR Part 11
Workbench Professional addresses the requirements of this standard through the Document Control Module with features such as full audit trails. These audits are available both as an electronic record, and can be printed as an integral report.
A full workflow can be defined at a system level, i.e. all records are controlled in exactly the same way, at a group or “rules” level, i.e. all records matching certain criteria, or at an individual document level. Access to change this workflow is both controlled and traceable.