CSols Inc. was selected to perform the validation and deployment of an Empower 3 FR4 Chromatography Data System in-place upgrade for a global Biotech/ Pharmaceutical Company. The upgrade was required to support Windows 10 on the new Empower 3 FR4 platform on all workstations and to provide a more detailed and defendable validation package for QC, R&D, and Technical Development labs in Raleigh, NC, Cambridge, MA, and Solothurn, Switzerland.
Objectives and Challenges
The goal of this project was to deploy an Empower 3 FR4 upgrade to five (5) labs running Empower 3 FR3 and deploy one new lab. Additionally, since the company was moving to Windows 10 and wanted to address issues in their existing validation of Empower 3, it was a perfect time to generate a new, complete validation package. Without this upgrade, the deployment of Windows 10 would not be possible in the labs and gaps in the validation of the existing Empower 3 FR3 system would have left the company at risk.
To achieve these objectives, there were a few hurdles to overcome:
- Upgrading in place required a concentrated effort and constant communication with the impacted laboratories since the changeover would require downtime for an extended period.
- The time for data backup and restoration was more than originally estimated since the structure and amount of data were complex and large.
- License corruption was encountered on a server and the existing version of Empower 3 could not be uninstalled.
- Due to firewall settings at one of the labs, Empower 3 FR4 failed to function properly. Additional effort was required to resolve the issue.
CSols’s Role in the Solution
This effort included the following key tasks and deliverables:
|1. Project Management
|2. Subject Matter Expert
|3. Validation Lead
- All gaps from the previous validation of Empower 3 FR3 were addressed in the Empower 3 FR4 validation
- Empower 3 FR4 is fully supported by Windows 10 on all workstations and LAC/e boxes 3. The creation of a new requirements document captured existing business process plus new Waters functionality
- Risk was reduced to the business and to the enhancement project itself due to the incrementally executed testing and validation plan that was based on a well-designed and scientifically appropriate test cases
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