21 CFR 11 Resources
At Ofni Systems, we want to help your business be compliant with 21 CFR 11. These are some useful 21 CFR 11 resources, including a discussion of the specific requirements of the 21 CFR 11, case studies, sample code to meet the technical requirements of 21 CFR 11, and links to FDA guidance documents. If you need additional training or consultation, contact Ofni Systems.
21 CFR 11 Resources by Ofni Systems
Case Studies from Ofni Systems
- Ofni Systems provided products and services to the Dana-Farber Cancer Institute to assist them with making their spreadsheets compliant with 21 CFR 11.
- Ofni Systems helped Mi-Co to demonstrate compliance with 21 CFR 11.
21 CFR 11 Resources and Guidance from the FDA
Access Tools from Ofni Systems
Access Tools from Microsoft
Access Security Manager Add-In (Access 97)(Access 2000/2002(XP))
21 CFR 11 Tutorial