A leading medical device manufacturer sought to validate an existing manufacturing execution system (MES) for printed circuit boards (PCB). This system facilitated the integration of CAD design files with BOM files to manage and deliver PCB assembly configurations and manufacturing process plans to a factory model schema that included both automated and manual processes. The system provided traceability of individual PCB serial numbers to their parent assembly panel, production lot, and design configuration version, as well as traceability of placed components and materials to their manufacturer lot. The system also provided production workflow enforcements and an audit trail of operations performed during the execution of PCB production and during service of after-market returns.
The project also encompassed a software version upgrade from the software vendor. The software, an over the counter configurable MES package, had been in use in a validated state at the client’s manufacturing facility for a number of years. However, the upgrade provided new opportunities for the client to improve on a number of existing operations and quality management considerations. The client also desired to improve their compliance with updated internal validation policies and procedures. As a result quality system documentation and training were designed and implemented to clearly define intended use of the system to support controlled manufacturing and quality assurance processes.
Performance Validation professionals were called upon to validate this system to ensure quality and compliance with the Quality System Regulations and ISO 13485:2003.
The PV Advantage
Performance Validation provided a dedicated team with a Validation Specialist experienced in managing Computer System Validation projects. Modeled after ISPE’s GAMP 5, a risk based approach was executed to maximize quality, efficiency and minimize cost.
The Validation Strategy for the local MES solution included:
- Vendor Evaluation – A vendor audit was conducted to evaluate the vendor’s quality system and Software Development Life Cycle process. A review of development testing demonstrated adequate functional testing. Overall the vendor evaluation provided a high level of confidence in the integrity of the MES software product and vendor testing.
- A risk based approach was taken by classification of the application as a commercial-off-the-shelf (COTS) software. Additionally the users completed a risk assessment based on the intended use (the workflows) of the application.
- Testing requirements for the MES were developed based on the output of the vendor audit, the risked based approach and input from the client SMEs.
- To minimize business impact the MES qualification/validation testing was completed in a test environment and migrated to a production environment.
- Test environment IQ (establish validation environment)
- Test environment OQ (full functionality and workflows)
- Production environment IQ (migration, equivalency to validation environment, and upgrade)
- Production environment OQ (critical functions)
- Validation deliverables included:
- Validation Plan
- Vendor Assessment
- Risk Assessment
- User/Functional Requirements Specification
- Test Plan
- Installation Qualification of software and Infrastructure
- Operational Qualification functional testing of work flows
- Trace Matrix
- Test Summary Report
- Validation Summary Report
Performance Validation provided the necessary services and solutions to complete the MES system validation project, while remaining flexible and responsive to the customer’s schedule and budgetary constraints. The validation project was completed successfully, and the upgraded MES system was placed back into production in a timely manner to the customer’s satisfaction.
A subsequent FDA audit of the MES system identified no findings, and resolved an FDA finding from a prior audit.
The advantages of tailoring each validation effort based on system risks and complexity were realized. Through complete and quality-driven validation planning, testing was minimized and remained focused on the system’s intended use and all critical quality attributes. This ensured that timelines were met without sacrificing quality.
This medical device manufacturer now has a validated manufacturing execution system (MES) for printed circuit boards (PCB) system which meets their intended use, and Quality System Regulations / ISO 13485:2003 compliance needs, while allowing for managed change control and continuation of a validated state for the future of the system.
For additional information, contact:
Kevin Marcial, Validation Engineer
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile