Aga Linde Healthcare (ALH) manufactures pharmaceutical gases and needed a new and compliant way to handle quality documentation. ALH wanted to centralise the storage of documents and make it possible for subsidiaries around the world to store, share and exchange quality documents. Athena Solutions (AS) was engaged to do a technical evaluation and implementation of a new document management system.

On the basis of ALH's requirement specification an evaluation of thirty systems was boiled down into three possible systems. ALH chose Documentum. Documentum was the only system that fulfilled ALH's requirements of support, usability, pharmaceutical references, regulatory requirements from FDA (Food and Drug Administration) and electronic signatures.

Athena Solutions did the configuration and implementation. A pilot installation was done in Scandinavia together with training for advanced users (Super Users) and authors (Contributors) of documents.

ALH does not use quality documents on paper anymore in Scandinavia and use digital signatures to approve SOP's (Standard Operating Procedures) and other documents.

The Documentum installation is now being validated (automated systems in the pharmaceutical industry must be validated). A validation means that external consultants inspect the process from installation and configuration to usability and system documentation, in order to verify that all requirements of the system are fulfilled. The whole project follows the GAMP guidelines.

A roll out of the system to 35 countries is planned and will be performed in stages.