Driftpin Case Study: Computer Software Validation for CellPort Software

How Driftpin collaborated with a leading GxP software provider to meet their clients' computer system validation needs

June 11, 2024

Background

CellPort Software is a leading provider of lab management solutions. Their laboratory digitalization products are crucial for pharmaceutical and biotech companies aiming to expedite the development and approval of new therapies. A recent CellPort Software release targeted GxP clients and CellPort needed to ensure the release met the rigorous validation standards required by its user community. They enlisted Driftpin Consulting to develop the software validation strategy, project manage the validation process, and ensure compliance with regulatory requirements and alignment with client expectations.

Objectives

  • Establish a comprehensive, risk-based validation strategy for the software release and subsequent maintenance that adheres to existing FDA guidance and leverages the September 2022 draft, “Computer Software Assurance for Production and Quality System Software”.
  • Ensure the validation package meets client expectations and regulatory requirements.
  • Create a sustainable testing strategy with CellPort’s QC and QA teams that relies on critical thinking and a clearly delineated “intended use of the system” to set clear boundaries for testing each release.
  • Generate documented evidence of validation activities.
  • Manage the Installation Qualification (IQ) process with the development team.
  • Ensure Operational Qualification (OQ) coverage and traceability with the QC Testing team.
  • Create standardized Performance Qualification (PQ) scripts for client use.
  • Establish a release strategy and cadence with the Release Management team.
  • Manage client feedback during their PQ and UAT phases.
  • Track client-reported bugs and manage maintenance release schedules.
  • Communicate effectively with clients throughout the validation and post-release phases.

Scope of Work

Validation Strategy and Planning:

  • Developed a comprehensive validation strategy that addressed all phases of the software lifecycle.
  • Communicated the strategy to CellPort’s clients to ensure transparency and alignment with their needs.

Coordination with Internal Teams:

  • Collaborated closely with CellPort’s Quality Control (QC) and Quality Assurance (QA) teams to coordinate testing efforts.
  • Leveraged test management software to streamline testing processes and documentation.

Documentation and Evidence Generation:

  • Generated documented evidence to support validation activities, ensuring compliance with regulatory standards.
  • Managed the Installation Qualification (IQ) process, ensuring all installations were correctly performed and documented.

Operational Qualification (OQ):

  • Ensured thorough coverage of all operational aspects of the software through rigorous OQ testing.
  • Maintained traceability and documented evidence to demonstrate compliance.

Performance Qualification (PQ):

  • Created standardized PQ scripts that clients could use to validate the software in their specific environments.
  • Ensured the scripts were comprehensive and easy to follow, facilitating client adoption and use.

Release Strategy and Post-Release Management:

  • Established a clear release strategy and cadence, ensuring clients were well-informed about upcoming releases and updates.
  • Managed the post-validation release process, tracking client-reported bugs and coordinating maintenance release schedules.
  • Developed detailed release notes and communicated maintenance schedules to clients to ensure they were prepared for updates.

Challenges

  • Client Communication: Needed to effectively communicate the validation process and align it with client expectations and needs.
  • Supplier Management: Coordinated efforts with multiple suppliers who played significant roles in the validation process.

Resource Allocation: Consolidated substantial validation tasks within a limited internal team, ensuring no single resource was overburdened.

Solutions and Outcomes

Effective Communication:

  • Driftpin ensured clear and continuous communication with CellPort’s clients throughout the validation process, addressing concerns and aligning the validation package with client expectations.

Supplier Coordination:

  • Managed relationships with multiple suppliers to ensure all validation activities were completed on time and met required standards.

Efficient Resource Management:

  • Developed a RACI matrix to distribute validation tasks effectively among internal team members, preventing resource overload.

Successful Validation:

  • Completed the validation of CellPort Software’s 2023 release within the established timeline, providing robust documented evidence and ensuring compliance with GxP standards.

Enhanced client confidence in the software’s reliability and compliance, contributing to successful product adoption and satisfaction.

Conclusion

Driftpin Consulting played a crucial role in the successful validation of CellPort Software’s major release. By developing a comprehensive validation strategy, coordinating with internal and external stakeholders, and ensuring rigorous documentation and compliance, Driftpin helped CellPort meet regulatory requirements and exceed client expectations. This initiative ensured the software’s reliability and regulatory compliance and reinforced CellPort’s reputation as a trusted provider of clinical technology solutions.

For more information on how Driftpin can help your organization achieve its software validation goals, contact us at: