The Client
An American subsidiary of a large Japan-based pharmaceutical company.
Challenges
- Inadequate documentation on the processes, procedures, templates and guidelines with respect to 21 CFR Part 11 regulation requirements
- The existing systems boundaries were undefined
- Lack of awareness on regulatory requirements and compliance needs
Solution
- Assessed the systems for compliance to 21 CFR Part 11
- Identified the gaps in the systems with respect to the regulatory requirements
- Presented a detailed gap analysis report, remediation plan and roadmap
Benefits
- Generated a detailed gap analysis report for 21 CFR Part 11 compliance
- Detailed milestone-based plan to remediate gaps identified in IT process and IT infrastructure
- The company clearly understood the impact of 21 CFR Part 11 on their operation
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