Title 21 CFR Part 11 Validation Kit
Intland Software’s FDA Title 21 CFR Part 11 Validation Kit helps our medical and pharma users access best practices for complying with electronic record and e-signature regulations when using codebeamer.
In the handling of electronic records, FDA has a very narrow description of cases where 21 CFR Part 11 applies. As per the regulation, the system supporting electronic records needs to be validated, audit trails have to be created, record retention managed, and record copying rules need to be defined.
This Validation Kit significantly reduces the time and effort investment of validating your computer system maintaining electronic records. The kit provides a great starting point for your validation activities, saving you a great deal of costs, internal resources, and man hours.
Intland Software’s codebeamer can be fully validated against FDA Title 21 CFR Part 11 as applicable to systems maintaining electronic records.
- Document export: Flexibility around exporting documents, including MS Word, Excel, or PDF export.
- Baselining: Create immutable snapshots of specifications and accompanying documents at the time reports are created.
- Electronic signatures: Apply e-signatures integrated into workflows, or via the Review Hub. Electronic signatures are timestamped, human-readable, and may be exported into electronic records.
- Audit Trail Reporting: A timestamped, computer-generated log of all Audit Trail activities may be simply created to comply with FDA or other international requirements.