SUCCESS STORY
Split and Upgrade OpenText™ Content Suite 16.2 incl. RIMS and Xybion QMS modules into separate instances
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CUSTOMER
Industry: Life Science
Location: Switzerland, worldwide
Employees: ~2500 -
RESULTS
1) OpenText Content Suite has been cloned, QMS content eliminated and upgraded to version 20.2;
2) Separate instance with Xybion QMS module and only relevant content on OTCS version 16.2.2 has been created;
3) Updated CS 20.2 received new functions required by business.
PROJECT SCOPE
Installation of a new GxP instance of OT CS 16.2.2 with RIMS and Xybion QMS module. Complete DB copy incl. content. Separation of content and configuration in both systems by cleaning up the database after the copy.
Upgrade of the initial OT CS instance to 20.2 without Xybion QMS. Complete validation of new OTCS QMS instance, re-validation of the initial instance.
Challenge
Our Swiss LifeScience customer operated a GxP validated OpenText Content Suite 16.2.2 incl. RIMS (Regulatory Information Management) and Xybion QMS (Quality Management System) modules. The End of lifecycle of version 16.2 together with additional business requirements was demanding an action.
QMS vendor Xybion was unable to provide a new version of the QMS module compatible with the target CS version 20.2 making an upgrade of the system impossible.
After an analysis of the options, the customer decided to "carve-out" the QMS module with it`s processes and related content into a separate new OT CS instance. In addition, OpenText Archive Server needed an upgrade from version 16.2.2 to stay compatible which was achieved with the new version 20.2.
Alexandra Freitag, Partner IseoSolutions
“Upgrades of your Core LifeScience Systems keep your work secure and offer new functionality to improve. If you are blocked by a vendor or Software module you need to find a way to proceed. The approach we had chosen, secured both: the existing investments and content as well as a way forward.”
CUSTOMER'S GOAL
Upgrade
Upgrade the OpenText Content Suite incl. RIMS to version 20.2 to ensure the lifecycle, allow patching and enable new functionality for business users.
Independent operations
Ensure all QMS related functions can be operated independently from the main OT CS instance, including connected systems like OT Archive Server and SAP VIM.
Ensure integrity & validation
Ensure integrity & validation of the process and data clean-up: only one copy of a document per system, new instance needs to be validated.
IMPLEMENTED SOLUTION
Installation of a new OpenText Content Suite 16.2.2 instance incl. RIMS and Xybion. Copy of the database and content from the original to the new system.
Scope of all content and configuration to be kept in one or another systems - ensuring data integrity in having documents in only one system. Clean-up of not relevant content in configuration from both systems. The procedure has been repeated and validated in all 3 environments.
Technical preparation of the original system for the upgrade: replace WebDAV by Office Editor, replace document ID generator from QMS, remove the QMS module, upgrade of the OpenText Archive Server to version 16.2.2 - compatible with both: the current and the target version of OT CS, and other connected systems like SAP VIM.
PROJECT DELIVERABLES
We have been responsible for the overall Project Management and Validation of the project as well as the technical execution of the Archive Server upgrade;
Upgraded validated OpenText Content Suite 20.2 without Xybion QMS;
Separate instance of validated OpenText Content Suite 16.2.2 with Xybion QMS;
Upgraded OpenText Archive Server to 16.2.2;
Approx. 1,2 Mio documents and 800K Workflows have been deleted from the new OT CS QMS instance;
Complete validation of the new QMS Xybion system with set of validation documents;
Re-validation and update of Evergreening validation documents of the original system.