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.
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