FDA 21 CFR PART 11
zenon consistently meets FDA 21 CFR Part 11 criteria across all of its modules. The zenon principle of setting parameters rather than programming, the high level of object orientation and managing multiple projects saves up to 90% of validation costs for new projects. FDA 21 CFR 11 stipulates that all electronic data must meet certain requirements to ensure comprehensive documentation of all processes that is safe from manipulation. Thus, a significant element in FDA 21 CFR Part 11 compliant projects is the audit trail. Audit Trail in Editor zenon records all project changes in the Editor, without exception (new creation, changes, deletions, copy and import of XML import). Changed object, change type, timestamp, user, workplace, old value, new value and a field for free comments are recorded. Data is saved in the project database. Data can be viewed in a clear list, filtered or exported in CSV format. This enables full traceability at the Publisher. Additionally, zenon's versio...