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FDA Audit Support

In 1997, FDA issued 21 CFRPart 11, and the relevant industry guidelines in 2003 so as to refine the rules. In Part11 regulations, Electronic records are considered to have the same effect as written records and handwritten signatures. 21 CFRPart 11 is widely accepted and complied by American institutes of biological pharmaceutical companies, hospitals, and laboratory. Since the issue has been extended to the world, although not mandatory, it is accepted by Europe and Asia. The United States, as the most important component of the global biomedical industry, has great influence. When the medicine, biological medicinal equipment or information systems need to be sold to pharmaceutical companies and researchers in the United States, they should comply with the provisions of the 21 CFRPart 11. If violated, the FDA can deprive their rights to export to the United States according to the regulations.

1. Provide on-site support of FDA audit
2. Review documents submitted to FDA
3. Guidance of answering to FDA questions
4. Ensure the success of audit process

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