Situation

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:

  1. Upgrading in place required a concentrated effort and constant communication with the impacted laboratories since the changeover would require downtime for an extended period.
  2. The time for data backup and restoration was more than originally estimated since the structure and amount of data were complex and large.
  3. License corruption was encountered on a server and the existing version of Empower 3 could not be uninstalled.
  4. 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

  • Set expectations
  • Set schedule
  • Determine effort
  • Link appropriate tasks
  • Assign tasks
  • Coordinate all documentation
 2. Subject Matter Expert

  • Input on installations
  • Guide on configuration
  • Address deployment issues
  • Perform testing
  • Resolve issues
 3. Validation Lead

  • Create and review validation documents
  • Execute and review testing
  • Work with company to address testing issues

Benefits

  • 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

Check out more projects that CSols has worked on by clicking here.

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