Roadmap to Achieve FDA Compliance
Mandated by the FDA for electronic records and signatures, 21 CFR Part 11 delivers extensive requirements spanning data integrity, access controls, audit trails and more that demand alignment.
Our gap analysis specialists compare your current state systems against Part 11 line-by-line to reveal compliance gaps around:
- – Data Integrity Features
- – Password Controls
- – Identity Management
- – Audit Trail Details
- – Backups and Recovery
- – Validation Status
- – SOPs and Policies
“The gap roadmap Valitech provided became our guide to modernize infrastructure and workflows for achieving Part 11 readiness.”
VP IT, VeraTech
Our analysis includes:
1) Workshop to Map Processes and Systems
2) Compare Current State to Part 11 Mandates
3) Identify and Prioritize Gaps
4) Develop Risk-Based Remediation Plans
5) Track Status to Closure
With a data-driven roadmap tailored to your environment, leverage our expertise to systematically achieve FDA alignment for your digital systems and instill stakeholder confidence.