Compliance

As a manufacturer or distributor of healthcare products, you have to demonstrate compliance with a multitude of regulations on product manufacturing, marketing, and distribution. Drug pedigree laws, 21 CFR Part 11 requirements, and structured labeling guidelines are just a few of the strictures on managing and communicating product-related information.

Ensure that product information is current and compliant for all processes and documents

Enterworks Enable lets you…

Help your enterprise meet these requirements

  • Ensure that product information is always current for both processes and documents that depend on it
  • Maintain audit trails on all process participants and their actions in the process
  • Support XML-based structured label formats for compliance with SPL and PIM DES