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This article was originally published in the August 2011 edition of EduQuest's publication: EduQuest-ions & Answers.
What objective evidence does an FDA investigator expect to find at your company to demonstrate you have an actual Quality System?
Here are seven specific, tangible items you should be able to provide to the FDA upon request:
- Written Quality Policy
- Written Quality Plan
- Quality System Procedures and Instructions
- Management Reviews -- and evidence these reviews are actually being conducted
- A Management Representative -- with appropriate knowledge, training, experience and authority
- Established Organization Structure -- including provisions for responsibilities, authorities, and necessary resources
- Quality Audit Procedures -- with evidence that audits of the quality system, including re-audits of deficient matters, are being conducted
Email Martin Heavner. If your question is selected for an upcoming issue of EduQuest-ions & Answers, you'll receive a complimentary CD containing the Investigations Operations Manual (IOM), the 450-page inspection "bible" developed by FDA for its own inspectors.