FDA 820 Express helps you jump-start your 21CFR Part 820 compliance initiative.

With FDA 820 Expressyou can easily assess your current environment, automatically analyze it for compliance with the 21CFR Part 820 regulation, and quickly generate a customized, actionable plan for bringing your current environment into compliance.

FDA 820 Expressprovides a user-friendly, web-hosted environment which you can use effectively, regardless of the depth of your 21CFR Part 820 knowledge. It includes a comprehensive, dynamically driven questionnaire covering all requirements of the regulation. The questionnaire is thoroughly annotated with links to glossaries, specifications, and help files to help you come up to speed on the 21CFR Part 820 regulation rapidly. Once you have answered the questionnaire, you can perform gap analysis at the press of a button. FDA 820 Express compares your environment against its 21CFR Part 820 knowledgebase, detailing the gaps which exist in your environment and generating a customized, actionable plan for achieving compliance.

FDA 820 Express significantly reduces your FDA learning curve, enables you to leverage your existing processes to achieve compliance, and reduces your time-to-certification. After certification, you can use FDA 820 Express to perform efficient and detailed self-audits to ensure that your environment remains compliant.

To learn more about FDA 820 Express, download our datasheet.

FDA 820 Express datasheet