A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team.
For the electronic TrackWise CAPA management system, the client required computer system validation support to complete the qualification testing phase of the project.
For the TrackWise complaint handling system, the client required full end-to-end validation services, including validation leadership for personnel involved in the final qualification processes.
The following business considerations were addressed by the TrackWise complaint handling system:
- compliance with applicable regulatory body requirements
- multiple data entry sources, including TrackWise® project forms, a web-based end user form, and a mobile iPad application for company representatives
- interface with multiple data hubs for acquisition of product, personnel, and customer record data
- complex schemas for electronic record relationships and process workflows to be performed by multiple user permission groups
- electronic submission of adverse event reports via web-based XML solutions to the FDA (Medical Device Reports) and the appropriate European Competent Authority Agency (Medical Device Vigilance)
- adverse event reports for many specific countries, delivered in native language and agency prescribed formats, using custom developed Crystal reports
- tracking, trending, reporting, and automatic notifications for day-to-day complaint record management, to enable timely business decisions and efficient work processes
These projects, extensive in their scale and complexity, were subject to strict deadlines for implementation and an aggressive schedule.
The PV Advantage
Performance Validation provided the client with an experienced validation project team and Project Leader. Based upon project needs, Performance Validation responded by providing:
- a risk-based validation based approach, modeled after ISPE’s GAMP 5, employed to maximize project validation quality and efficiency
- a working partnership with the client Regulatory and Quality Assurance representatives to ensure that the new systems were compliant with 21 CFR PART 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, 21 CFR PART 820: QUALITY SYSTEM REGULATION, and 21 CFR PART 803: MEDICAL DEVICE REPORTING
- experienced validation planning and coordination
- effective collaboration with the IT Business Analyst, Development Team, and IT Quality to develop a comprehensive suite of system documentation that encompassed all of the system business requirements, functional requirements and design specifications, and testing documentation
- system documentation that was intentionally designed to facilitate testability and ready traceability of all system configuration and functionality
- detailed functional review of the system, performed at the clients request prior to initiation of the project’s formal validation testing phase, to reconcile the system development to the approved requirements and specifications
- comprehensive testing strategy, test scripts, pre-qualification (dry run) execution, and script error corrections prior to initiation of formal validation testing
- efficient execution of validation test scripts, including timely deviation reports, resolution management, and validation test summary reports
- flexible and decisive validation solutions to accommodate business requirement changes during the validation testing phase
- knowledgeable and experienced system change control support following deployment of the validated TrackWise® systems
- formal periodic status reports along with frequent client interaction to provide stakeholders timely information regarding project management elements such as costs, timeline, and scope control
In order to accommodate demanding project schedules and deadlines, the Performance Validation team was committed to providing the additional man-hours necessary to ensure the client with on-time delivery of these validation services, and to provide the client project managers with peace of mind.
System validation activities for the TrackWise CAPA and Complaint Handling systems were completed on time, allowing the client to meet their overall system implementation deadlines.
Through the collaborative efforts of the Performance Validation team with all client stakeholders, the client was able to deliver top quality global systems that meet the business process requirements.
In subsequent internal and external audits of the system by the client and regulatory agencies (FDA) validation documentation delivered by the Performance Validation team, the systems were determined to be in an exemplary state of compliance with both client internal standards and regulatory agency requirements.
Following completion of the system implementations, Performance Validation team members were retained by the client to ensure continuation of compliance with a high standard of quality in support of system life-cycle change control and to maintain the systems in a validated state.
Performance Validation provided the client with:
- high quality validation project consultation, deliverables, and execution through understanding the project, the stakeholders, and validation quality expectations
- a validation approach custom designed for the scope and complexity of global information system
- flexible allocation of project validation team resources in response to project needs
- diligent attention to changes in system requirements, functions, and configurations throughout the development and validation cycles, with immediate assessment of impact to validation considerations, and follow-up revisions to all pertinent documentation
- affective communication and cohesive working relationships with all project stakeholders
- continued system life cycle change control support beyond the systems’ go-live dates
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CSV Services Manager