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Resources
At Ofni Systems, we want to help your business be compliant with 21 CFR Part 11. These are some useful references relating to 21 CFR Part 11.
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Case Studies from Ofni Systems
- Ofni Systems products and services used by the Dana-Farber Cancer Institute Click here to view.
Guidance from the FDA
- Draft Guidance for Industry; Part 11, Electronic Records; Electronic Signatures - Scope and Application - 2/20/2003 - Click here to view.
- 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 - Click here to view.
- Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002 - Click here to view.
- 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. - Click here to view.
- Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002 - Click here to view.
- Center for Biologics Evaluation and Research's Electronic Regulatory Submissions and Review web page. - Click here to view.
- International Conference on Harmonisation (ICH); Electronic Common Technical Document Specification - 6/14/2002 - Click here to view.
- Electronic Common Reference Document - Click here to view.
- Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures - Scope and Application - Click here to view.
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations (Oct. 2003) - Click here to view.
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