CMS shortens validation documents and timelines

To better handle its complex and voluminous regulatory documentation, Wyeth has piloted a content management system from Virtify. KMWorld reports that the drug giant chose the enterprise structured content management suite.

A key capability is that the application breaks down documents into components, allowing users to assemble them in a dynamic way based on business rules, and to make them specific to the piece of equipment being validated. Wyeth can reuse components when appropriate to build new content, rather than starting from scratch, says the KMWorld report.

Promising results of the Virtify system pilot included shorter validation documents and correspondingly shorter production time.

The structured content management suite is built on Virtx, an open, extensible architecture. Key elements include an Internet-based AJAX interface, lifecycle history and audit trails, infrastructure support for multiple databases and document management systems, and configuration for 21 CFR Part 11 compliance.

 - read the KMWorld article