Problem

The client needed to migrate existing business critical information from several outdated systems into a new Documentum system. The project demanded high quality and system validation which is a requirement in the pharmaceutical industry. They also needed new processes for governance of the future system.

Solution

Athena Solutions took on the whole assignment from vision to implementation. We:

• Created a business case to justify the budget
• Created a requirement specification
• Created an Information architecture for how to manage the documents. We aimed for a taxonomy that was easy to understand by end users, resilient and easy to adapt to changes.
• Implementation – Athena managed the configuration and customization of the new system. Migration was done by using a so called delta-technique, where data can be migrated while the old system is still running and when system transition occurs it is possible to stop for a shorter period and perform test and validation before opening up for users.
• System validation was performed in accordance with GAMP. Athena was responsible for validation and risk assessment. The documentation exceeded over 2000 pages, which in turn enabled a release with very few bugs and problems.
• Governance plan – Athena wrote many of the processes for maintenance and operation (Standard Operating Procedures). We also created a high level governance plan based on best practices from ITIL.
• Education – Athena developed educational material and held courses for super users, technicians and administrators.

The project methodology used was based on methods such as PPS and Scrum.

Result

Two old systems were migrated, more or less free from bugs (<5 bugs), into the new system. Through controlled change management new releases have already been made in the new document management system.