Medela selects QUMAS's compliance management solution



According to Medela, the implementation of DocCompliance will enable the company to manage a mix of documents, including policies, procedures, forms, drawings and specifications, and some manufacturing documents that will be scanned or imported from the manufacturing system.

We wanted to implement an electronic document management system that would enable us to meet all FDA guidelines, said Rick Russell, Director of Information Technology for Medela. My research identified QUMAS DocCompliance as a complete system that included validation scripting, and was 100% FDA-oriented. DocCompliance works on an Oracle database, which is important to us, since we are in the process of migrating that platform now. It will also integrate with our Microsoft Exchange e-mail system, so we can track the location and status of a given document at any time, via e-mail, giving us full control over that process.

System validation is now complete and the system rollout is underway. Following the installation of DocCompliance, Medela will implement eDocCompliance, a companion solution designed to Web-enable compliance management of regulated documents throughout corporate intranets.