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White Paper

Preparation for FDA 21 CFR, Part 11, and EU GMP, Appendix 11

Guide to Ensuring Technical Coherence in the Biosciences

Manufacturers of medicines and medical devices, as well as companies in other industries controlled by the FDA, must keep electronic records and signatures as a reliable equivalent to paper records. This White Paper presents EU and FDA regulatory standards. It also describes how NiceLabel solutions ensure proper compliance throughout the label's lifecycle. You will learn how NiceLabel integrates the labeling required to ensure compliance with biosciences with existing customer workflows and business information systems such as Oracle, SAP or other ERP systems.

In this book, companies can find a variety of printing and administration information for the software tools they need to comply with European Union and FDA regulations.

  • SAP
  • Oracle
  • Regulatory
  • FDA
  • Artwork Management
  • Labeling
  • Track and Trace
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