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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Enterprise labeling

For Single Site, Smaller Businesses

For Mid-sized or Growing Businesses

For Global Enterprises

For Clinical Trials

For Medical Device Small and Mid-sized Businesses

For Medical Device Enterprises

For managing Packaging Artwork

Why artwork management

Business applications overview

Address global labeling regulations

Varian integrates labeling with SAP

Zumtobel's Labeling Transformation

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