The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers. This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven motorized surgical devices.
The core of the new system was a software program designed to read data stored the device’s onboard programmable electronic control component, acquire real-time performance parameter values from the device, diagnose the state of “fitness” of the device by comparing the acquired data against a set of configuration specifications, and adjust the device software for optimum performance. The programming software was designed to interface with the devices’ software installation files and configuration specifications files, stored in controlled network directories, via network connection. At the end of the testing/programming sequence, a printable device history report was generated which includes all the recordable service actions and the device status at the time of service.
The new system also included a custom peripheral hardware fixture designed to mechanically interface with the devices at the battery/programming port, power the device, and provide logical connection to the onboard programmable electronic control component of the device. The interface fixture was also equipped with a connection port for a multimeter to allow the service technician to gather electrical current readings from the device during testing.
Due to the universal design of the battery/programming port and the onboard programmable electronic control component, the programming system would accommodate the servicing of a wide number of related device models, each with its own unique combination of device software application and configuration specifications.
Performance Validation professionals were called upon to complete the validation of this system while operating within the client’s new electronic validation system.
The PV Advantage
Performance Validation provided a dedicated team with Validation Specialists 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.
Performance Validation professionals worked closely with the client’s engineering team to ensure that all risks with regard to the medical device programming system performance across the range of affected device products was taken into consideration and mitigated. This approach was then duly documented in qualification.
The project for the device programming system included:
Initial Assessment: an initial assessment was documented to establish the system’s GMP impact and applicability to 21 CFR Part 11 regulatory requirements.
User Requirements Specifications document (URS): Given the URS document from the related production version of the device programming system (previously validated by the client) and engineering development reports for the new programming system, the PV CSV Validation Specialist was able to extract and derive the set of user requirements need to complete the URS.
Functional Design Specification document (FDS): Given the FDS document from the production version of the device programming system and engineering development reports for the new programming system, the PV Computer System Validation Specialist extracted, derived and modified the applicable sub-set of functional specifications need to complete the FDS.
Measuring System Analysis (MSA): MSA was performed and documented to qualify the use of a specified make/model of multimeter used in conjunction with the interface fixture to ensure the accuracy and reliability of the current readings. MSA was also performed against the use of a specified make/model of photo tachometer to be used by field technicians to measure the speed of rotation/oscillation of the device for manual entry into the diagnostic data set. MSA testing and documentation was developed and executed by a qualified PV Validation Engineer.
Computer System Validation Qualification (CSVQ):
The CSVQ testing documentation was developed and executed by the PV Computer System Validation Specialist. The client’s service engineering subject matter experts were consulted to ensure that their knowledge and experiences in testing and programming of the devices were considered to ensure reasonable mitigation of any known risks of failure in the testing and programming process.
The CSVQ included Installation Qualification (IQ) that verified:
- the controlled state of system related installation instructions and service manual documents
- the calibration of test instrumentation (multi-meter, tachometer)
- the test installation of the interface fixture hardware
- the test installation of the software system
- the controlled storage of the software backup files
The CSVQ included Operational Qualification (OQ) that qualified:
- the configuration of the testing configuration source data files to be logically interfaced by the system software during runtime (configuration values compared against approved product engineering design documentation)
- the functionality of all graphical user interface screens and components
- the fully automated software sequencing for testing and programming, with separate test cases designed to address specific device types under best case conditions
- the pass/fail and remediation logic associated with diagnostic, programming, calibration, and optimization
- the reliability of the software system to perform consistently over multiple test instances for multiple device models
- the application of the software system functionality to all device models for which the system was intended
- the specified design of the report and the accuracy of the data represented within the report
- Traceability of the CSVQ testing to its related User Requirements was established within the client’s new electronic validation system.
Performance Validation provided the necessary services and solutions to complete the programming system validation project, while remaining flexible and responsive to the customer’s schedule and budgetary constraints. The validation project was completed successfully, and the new medical device programming system was placed back production in a timely manner to the customer’s satisfaction.
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, while assuring the client that their programming system could be distributed to their service centers with full confidence.
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CSV Services Manager