The FDA does not formally review, approve, or disapprove products or services that enable people to comply with FDA regulations. FDA21 CFR Part 11 is a regulation with evolving compliance guidelines that can differ for various manufacturers and distributors of pharmaceuticals, cosmetics, and medical devices. As such, Irista is reluctant to represent our software as "Part 11 Compliant". The term is a misnomer because those who are subject to Part 11 are responsible for compliance with the rule and because achieving compliance involves implementing a collection of administrative, procedural, and technical controls. Irista feels that where the technical features of our software are required for 21 CFR Part 11, we would map those features to particular 21 CFR Part 11 controls and let prospective customers determine for themselves the potential suitability of the software in their own circumstances.
The design and deployment methodology used by Irista provides client's with the ability to easily qualify and obtain compliance with FDA's 21 CFR Part 11; Electronic Records; Electronic Signatures Validation. Irista's base functionality addresses key concerns in implementing a computerized system utilizing electronic records and electronic signatures. Controls in iristaWarehouse include user authentication; system access, controls, and security; audit trails; record retention, systems validation.
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