Software Vendor Audits
The FDA advises that, where third-party software is used for regulated activities, the manufacturer or clinical trial sponsor should audit the vendor’s design and development methodologies and should assess the development and validation documentation.
Our software vendor audits are conducted by a professional developer with over 15 years of experience in developing and deploying software for FDA-regulated industries. The audit covers the vendor’s development facilities, software development process, and quality assurance policies and procedures, including:
- Physical and logical security measures
- Backup/Restore and disaster recovery capabilities
- Staff training, education and regulatory competence
- Technical support services
- Defect reporting and resolution
- Quality system standards and procedures
- Source code escrow policy
21 CFR Part 11 Assessment & Remediation
With the recent withdrawal of six 21 CFR Part 11 Guidance documents, the “Final Rule on Electronic Records and Electronic Signatures” has proven to be anything but “final.” The subsequent publication of the “Scope and Application” guidance further blurred the landscape by placing heavy emphasis on the “predicate rules” in cGMP, cGLP and cGCP regulations.
Triligent’s standardized approach to 21 CFR Part 11 assessment and remediation is continually refined to keep pace with the latest developments in this evolving regulation. Our methodology has been successfully applied to hundreds of electronic record-keeping systems and delivers a cost-effective blueprint for remediation of non-compliant systems.
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