Controlled Document Management

The innovation process of high-tech products is increasingly regulated. Compliance requirement for documents and processes can go up to FDA standards level for Medical Devices. Traditional document management tools only manage but don't control compliance, and they do it as an overlay activity, adding complexity and friction.

Controlled Document Management provides enterprise-wide collaboration, document authoring and control across the entire document lifecycle. The solution is natively integrated with the actual engineering work-in-progress, enabling a common change process. Change impact and where-used analysis can be done any time, across all domains. The solution also maintains a traceable, reliable audit trial of changes and read & understood statements.