Challenge
- The client had initiated a global program in which equipment and IT-systems operating on local networks are migrated to a global process network.
- Various process equipment/IT-systems were migrated to the global process network at a local client site.
- Coordination between consultants performing the migration and coordination and review of relevant validation documentation.
- Updating relevant design documentation, requirement specification and completing combined installation and operation qualifications of the migration.
Solution - Proces
-
Initially consultants completed an analysis of and a guideline for the migration. This resulted in a list of documents to be updated.
-
Requirement specifications were assessed in order to identify requirement affected by the migration.
-
Based on the consultant’s analysis, combined installation and operation qualification protocols were completed and approved.
-
Due to a very limited timeslot for production shut down the activities were monitored closely by the management. After the individual migrations were completed a document describing mitigated risks was approved by QA and management in order to resume production prior to an approved qualification report.
Results
- Most validation plans were prepared in a light version due to the relatively simple validation activities.
- Migrations were successfully completed for, amongst other thing, washing machines, cooler positions, autoclaves, CIP/SIP.
- All validation non-conformities were handled and closed.