Contract Manufacturing Organization – Product Lifecycle Management (PLM) System Replacement

The Challenge

A large global CMO desired to replace an existing Product Lifecycle Management System. The new Product Lifecycle Management System would be housed at a corporate location, accessed globally and house all product data and documentation.  The project team was a diverse group consisting of the CMO, the software vendor, the software integrator, and Performance Validation.

The Solution

Performance Validation provided a dedicated team with a Project Leader experienced with managing IT validation projects and interfacing effectively with diverse project teams.  A risk based approach was executed to reduce and eliminate un-necessary or redundant testing of the proposed Product Lifecycle Management System.

• The Validation Plan identified the classification and strategy associated with the IT Infrastructure components, the application (GAMP5 category 4), and two JAVA based Applets that were developed to support a unique reporting function (GAMP5 category 5).
• A risk-based approach was taken to reduce the qualification burden.  This approach consisted of auditing the software vendor to evaluate: a) the software vendor’s quality system, b) the software development methodology in use and software development testing, and c) the software vendor testing of the base functionality of the software.  Based on the vendor audit results limited functional testing of the core application of the Product Lifecycle Management System was performed.
• The Validation strategy included:
  • Qualification of the IT Infrastructure elements.  The existing servers, OS, and other infrastructure software were evaluated to verify the infrastructure elements met the minimum recommended requirements of the application.
  • Configuration of the application was documented by the integrator.  The configuration was evaluated through the use of Conference Room Pilots (CRP) where the application was dry-run by the client using the draft workflow or use cases.  The configuration and workflows were modified based on CRPs and finalized and approved.
  • IQ of the application verified build /version installation of the application and testing of the configuration.
  • OQ – testing core functionality of the application was not performed based on the vendor audit.
  • PQ of the application focused on execution of the workflows from the user requirements.  The workflows verified the proper configuration of the software, verified functionally of software and that the software was suitable for its intended use.  This testing also included verification of operational and maintenance SOPs necessary to maintain a validated state and client specific procedures necessary to confirm 21 part 11 compliance.  PQ also included functional testing of the two Java Applets and workflow testing to demonstrate the applets were suitable for their intended use.
  • Validation deliverables included:
    • Validation Plan
    • User requirements (IT Infrastructure and Workflow)
    • Functional requirements (Elements outside of core functionality)
    • Configuration
    • Code review of the JAVA applets
    • IQ and IQ Summary
    • PQ and PQ Summary
    • Trace Matrix to trace requirements to testing
    • Validation plan summary report.

The Results

• The Product Lifecycle Management system was successfully implemented, validation was completed and the system was released for operational use.

The Benefits

Using a risk based approach to validate an off the shelf configured Product Lifecycle Management System allowed the client to focus on verifying that the application and supporting infrastructure was suitable for its intended use.  Focus was placed on verification that the IT Infrastructure met the requirements to run the application (given an assumed user load), that the application was configured correctly and finally that the workflows met the end users needs (user requirements).

Core functional testing of the Product Lifecycle Management System was performed by the software vendor.  This testing demonstrated core functionality of the software and was not repeated.  This approach reduced project cost, schedule and reduced the volume of the validation effort to what is truly necessary and value add to the client.

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Richard Van Doel, Board Chairman 

Performance Validation