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21 CFR Part 11
Pharmaceutical, medical device, biotechnology firms, and tissue/organ banks have heard of the Food and Drug Administration's Title 21 Code of Federal Regulations Part 11, which deals with electronic records and signatures (it's been in force since 1997). You may have read that the Food and Drug Administration (FDA) has changed this regulation and changed how they enforce it. You may even have read the surveys or warning letters regarding firms that are not in compliance, or that the FDA no longer gives firms multiple warnings prior to issuing a consent decree.
Validation Plus receives multiple calls each day from the pharmaceutical, medical device, biotechnology, and tissue/organ bank industries for computer validation assistance. Our Senior and Principal Consultants have worked with industry and agency representatives to interpret the regulations, and have been performing computer validation in accordance with 21 CFR Part 11 since 1998.
Validation Plus Senior and Principal Consultants have worked with and understand "metadata", audit trails, and security issues.
Our Services Include:
- Computer validation that meets the requirements of 21 CFR Part 11
- 21 CFR Part 11 gap analysis and application assessments,
Writing SOPs for compliance with 21 CFR Part 11
- Providing Recommendations For Validation (like a roadmap to successful validation)
- Identifying the web site that lists several dozen applications if you are considering new software
These benefits and our goal, customer satisfaction, have resulted in numerous letters of recommendation from pharmaceutical, medical device, biotechnology firms, and tissue/organ banks.
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