Situation

A global consumer healthcare company’s Ontario site used a validated version of Empower™ 3.  However, chromatography methods, data processing, and result reporting were not standardized.  Multiple laboratory groups used Empower and each spent a lot of time creating individualized Empower procedures. To improve efficiency, testing consistency, and quality among the groups and across the enterprise, the client began a project to enhance and harmonize their Empower 3 chromatography workflows at the Ontario facility and then deploy the improved and validated methods to all sites and laboratories.  To complete the project, the team engaged CSols, Inc. to document, develop, implement, and validate the new Empower 3 processes and reports.

Objectives

The client aimed to improve laboratory efficiency and regulatory compliance by enhancing and standardizing existing Empower processes and reports, including electronic signatures.  As part of this goal, the client aimed to improve product consistency and quality with an enterprise-wide deployment of the new processes and reports.

Challenges

  1. The project scope included a large number of methods; to standardize and automate these methods, many enhancements and configuration changes needed to be developed, implemented, and tested
  2. Maintaining regulatory compliance during the deployment required execution of a complex, incremental validation plan
  3. No design specifications existed for processing and reporting methods when CSols joined the project
  4. Some methods used multiple report variations, making a single report method unfeasible; each variation required development, documentation, and testing
  5. One method required a data entity that was not standard to Empower 3
  6. The report methods needed several complex calculations; each required development, documentation, and testing

CSols’s Role in the Solution

A CSols Empower configuration/validation expert

  • Configured report methods
    • Assay
    • Related Substances
    • Content Uniformity
    • Dissolution
    • Injection Precision and Carryover
    • Response Linearity
    • Noise and Drift
    • Standard Curve Assay
    • Gradient
    • Percent Area
  • Created design specifications for all of the newly configured processing and report methods
  • Configured three specialty reports for proprietary and confidential methods
  • Created custom fields to support reporting and calculation needs
  • Coordinated communication between stakeholders and team members

Benefits

  • The enhanced Empower 3 processing and report methods increased laboratory efficiency
  • The harmonized Empower 3 methods increased product consistency and quality across all laboratories
  • The well-documented design specifications facilitated an efficient and robust validation of Empower 3
  • The incrementally executed testing and validation plan was based on well-designed and scientifically appropriate test cases and reduced risk to the business and to the enhancement project itself
  • The addition of electronic signatures to Empower 3 processes reduced the time required to complete a report and minimized paper usage

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