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

• Introduction to 21 CFR 11, including the text of the regulations and how to implement the requirements
• An introduction to validation documentation, the documents that must be produced to demonstate compliance with 21 CFR 11
• Current Information about FDA Inspections for 21 CFR 11, written based on comments from CDER auditors
• Sample Letters of Non-Repudiation for Electronic Signatures, required by 21 CFR 11.100(a)
• 21 CFR 11 Blog, a collection of postings from Ofni Systems personnel about current issues in electronic record compliance

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

• Draft Guidance for Industry; Part 11, Electronic Records; Electronic Signatures — Scope and Application — Dated 2/20/2003
• Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach
• Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff — Dated 1/11/2002
• Center for Drug Evaluation and Research’s Electronic Regulatory Submissions and Review (ERSR) web page — This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.
• Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format — Investigational New Drug Applications (INDs) — Dated 3/26/2002
• Center for Biologics Evaluation and Research’s Electronic Regulatory Submissions and Review web page
• International Conference on Harmonisation (ICH); Electronic Common Technical Document Specification — Dated 6/14/2002
• Electronic Common Reference Document
• Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures — Scope and Application
• Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — General Considerations — Dated October 2003

Access Tools from Ofni Systems

• Sample code for Audit Trails

Access Tools from Microsoft

Access Security Manager Add-In (Access 97)(Access 2000/2002(XP))

21 CFR 11 Tutorial

• Introduction to 21 CFR 11 — An introduction to 21 CFR 11, including pages for:
  • Validation of Systems
  • Accurate Record Generation
  • Protection of Records
  • Limited System Access
  • Audit Trails
  • Operational System Checks
  • Authority Checks
  • Input Checks
  • Training
  • Policies for Using Electronic Signatures
  • Document Control