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Case

Network migration of IT systems

Pharma company

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.
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Michael Holt

Konsulent
IT & Automation / GAMP, GMP, Facilities & Equipment Validation, Computer System Validation