Situation

A specialty pharmaceutical company focused on developing, manufacturing, and marketing generic and branded products sought to increase efficiency and harmonize processes in their R&D and QC laboratories across the enterprise. Their Waters Empower™ 2 CDS was nearing end-of-life support and management elected to upgrade to Empower 3 and deploy the solution from a central point via Citrix. The new version of Empower 3 would automate labor intensive analyses like dissolution. The client engaged CSols Inc. to complete the Empower upgrade, system configuration and enhancement, and system validation.

Objectives

The client aimed to keep their applications under continued Waters support by upgrading to Empower 3 and accessing via Citrix. They also wanted to leverage Empower e-signatures, dissolution support, and calculation functionality to improve efficiency and eliminate paper processes.

Challenges

  1. Remote desktop deployment: when CSols began the engagement, Citrix had not been tested or deployed at any sites
  2. Out-of-date firmware: to complete the Empower upgrade, many instruments required firmware upgrades and requalification
  3. Limited resources: there was no project manager to drive the firmware update and Citrix projects.
  4. Suboptimal acquisition server: Instrument and LAC/E32™ box combinations were not optimized and required additional time and effort to upgrade
  5. Broad scope: Both QC and R&D analytical labs needed to share the same system and additional project time was needed for harmonization
  6. Limited expertise: there were no experienced Empower SMEs to complete project activities or update SOPs
  7. Project changes: The system owner role and implementation scope changed mid-course, causing project delays

CSols’s Role in the Solution

  • Project Manager
    • Developed project plans and timelines
    • Coordinated multiple related projects: Citrix implementation, firmware upgrades, Empower 3 upgrade
    • Managed project communications among teams and with management
    • Managed a multidiscipline project team including client resources, vendor resources, and CSols resources
  • Empower Configuration SME
    • Contributed to creation of lifecycle documentation
    • Led system configuration requirements gathering sessions
    • Executed system configuration
    • Developed custom fields, calculations, and reports for three laboratory process workflows
    • Developed and configured system suitability calculations for dissolution methods
    • Assisted with developing validation and production environment software IQs
  • Empower Dissolution SME
    • Assessed dissolution process workflow needs
    • Developed user requirements specifications (URS), functional requirements specifications (FRS), and test cases for dissolution methods
    • Developed custom fields, calculations, and reports for dissolution methods
    • Created SOPs for Empower dissolution methods
  • Empower Process SME
    • Performed configuration for instruments, Citrix implementation, electronic signatures, and system timeouts
    • Created SOPs for end users, system administration, and backup and archive processes
    • Developed request forms for system administration tasks
    • Performed reviews of completed test scripts and executed test script dry runs

Benefits

  • Implemented a standardized and up-to-date Empower 3 system that met QC and R&D lab requirements as well as regulatory guidelines
  • Increased efficiency by replacing spreadsheet processes with Empower Dissolution Module
  • Improved compliance and user experience and decreased training time via optimized SOPs
  • Decreased time and paper required for review and approval through automating Empower’s electronic signature process
  • Optimized LAC/E32™ box configurations increased data quality and process efficiency

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