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21 CFR Part 11 Data Management are the basis of Data Integrity

Accurate and complete data management and tracking is of critical importance in pharmaceutical production. The United States FDA regulation 21 CFR Part 11 addresses how pharmaceutical manufactures are required to collect electronic records and signature.

In today's environment where the importance of data management during production is increasing, the term "FDA 21 CFR Part 11" is frequently heard. Anritsu has published an explanation of this regulation and the features it offers to support compliance. The following is a portion of the content described in the materials. ● What is "FDA 21 CFR Part 11"? ● Why is data management necessary? ● How can data reliability be secured? ● Anritsu's compliance with Part 11 For more detailed information, please refer to the related external links and PDFs. If you have any questions or requests, please feel free to contact us.

  • Pharmaceutical and cosmetic factory software and systems
  • Manufacturing Inspection Equipment

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