Medical Device Programming System Validation

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 Solution

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 Benefits

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.

For more information please contact:

Kevin Marcial,
CSV Services Manager
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile

FMEA Training

The Challenge

A biomedical research company sought to increase worker knowledge in the use and application of the Failure Mode Effects Analysis (FMEA) quality tool.  The company desired a pragmatic approach with a combination of theoretical understanding of how the tool might be used, and a practical application of the use of the tool with one or more current products.

The solution

A Performance Validation Principal Engineer, with experience in Pharmaceutical, Medical Devices, and Combination Products who is also an American Society for Quality Certified Quality Engineer was selected for this project.

Performance Validation coordinated with the client point of contact to develop 2-day training approach that focused on the value add of the FMEA process in product development (risk identification, risk ranking, and mitigation), and less on the mechanics of risk priority numbering (RPN) calculations.  This resulted in the following approach:

  • Pre-work: Basics of FMEA and quality tools to gain a preliminary understanding of the tool prior to training.
  • Session 1: Classroom portion on FMEA process, quality tools, and supporting techniques.
  • Session 2: Practical FMEA generation. A facilitated discussion through the FMEA process of brainstorming/failure identification for 1 or 2 client selected projects.
  • Session 3: Practical FMEA generation continued. A facilitated discussion through the FMEA process of scoring, RPN generation, and mitigation of risks.
  • Session 4: Classroom session on integration of quality tools and techniques such as use of Ishakawa diagrams to identify Critical Quality Attributes, Failure modes and analysis. How to use FMEA in:
    • Product design to prevent or mitigate failures.
    • Design manufacturing process that prevent or mitigate identified risks.
    • Develop QC plans that detect failures anticipated by the FMEA.

The Results

The training was successfully completed over a 2-day period with approximately 15 client staff.  All required training objectives were met.  The staff participating in the training were all scientists with prior exposure to hazard analysis as part of the product development process.

The Benefits

Client staff who participated in the training obtained a solid foundation in how to conduct and integrate the Failure Modes Effect Analysis into product design and design transfer, specifically use of the FMEA:

  • Identified new design requirements on several new product development projects.
  • Helped identify specific manufacturing controls that could prevent problems and also can make troubleshooting more straightforward if failures occur.
  • Reduced reliance on Functional Testing of finished product, and helped identify more specific tests and tests that can be moved “upstream” in manufacturing.

For additional information, contact:
Brad Henry
Vice President  & Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241

Project Summary – SCADA Validation for Medical Device Assembly

A leading medical device manufacturer sought to validate a new SCADA (Supervisory Control and Data Acquisition) system to be used in support of the assembly processes for both an upgraded product line and a new product line. This project launched the client’s initiative to leverage electronic process control technologies to improve efficiency and quality control of their manual assembly operations. It also represented their first step toward establishing electronic process records to be included in a long-term data storage solution for device history records.

The system leveraged SCADA technology for:

  • security, user permissions, and electronic signatures
  • acquisition of work order and serial number data via ERP interface
  • printout of barcode and information labels for sub-assemblies and finished product
  • establishment of parent/child relationships for sub-assembly and final assembly serial numbers
  • management of sub-assembly inventories
  • tracking of sub-assembly and main assembly serial numbers throughout the process
  • enforcement and real-time monitoring of build order sequencing
  • display of operator instructions and error messaging
  • determination of calibration status for inspection instrumentation and expiration status for sub-assemblies
  • control of activation status and operating parameters for interfacing equipment assets (i.e. hand tools, fixtures, automated presses, laser markers, conveyances, etc.)
  • acquisition of specified device history data generated in execution of the build order
  • supervisory functions for handling nonconformities and intervention
  • generation audit trails records for changes to build order configuration
  • guidance and recording of operator pick parts selection

The applied SCADA system features included:

  • GE Proficy HMI and iFix SCADA software applications
  • Microsoft SQL Server
  • Citrix Server/Receiver
  • Multiple workbench dedicated PC clients and peripheral installations
  • Integrated PLC, IO, and Ethernet communication with process hardware systems

Performance Validation professionals were called upon to validate this system to ensure quality and compliance with the Quality System Regulations and the client’s procedures and practices.

The PV Advantage

Performance Validation provided a dedicated Validation Specialist experienced in the delivery and execution validation documentation for SCADA projects.  Working closely with the client’s engineering validation team and quality assurance personnel, the PV Validation Specialist followed their established validation plan and user requirements to deliver the necessary system documentation and testing.

The Solution

The Validation Strategy included:

  • A risk based approach was taken by classification of the application as a commercial-off-the-shelf (COTS) software.  A failure mode and effects analysis was completed to assess the level of testing to be conducted to ensure that any identified risk related to configuration and custom coded functions was mitigated.
  • Testing requirements for the SCADA system were developed based on the findings and recommendations of the System Risk Assessment document and input from the client’s subject matter experts.
  • Due to the high level of integration, qualification/validation testing was completed in the production environment and incorporated the functionality of interfacing production hardware and software assets.
  • Installation Qualification (IQ) verified the installation of the:
    • Database Server, Application Server, and Terminal Server platforms and software installations
    • GE iFix application server installation
    • SQL Server database installations and configurations
    • network hardware installations (PLCs, I/O modules, switches)
    • hardware configuration and software installations for 20+ workbench dedicated thin-client workstations
    • logical continuity (assets<>IO/PLC<>database<>HMI)
    • software storage and version control
  • Operational Qualifications (OQ) verified the functionality of the:
    • logical security and electronic signatures
    • permission-based HMI screen navigation
    • fully integrated end-to-end build order executions with process enforcements
    • negative testing and error handling
    • supervisor intervention functions and related accountability
    • system audit trails and process data logging for electronic device history records
  • Validation deliverables included:
    • Validation Plan (revision)
    • System Risk Assessment (integrated test planning)
    • User Requirements Specifications (revision) / Requirements Trace Matrix
    • Functional Design Specifications
    • Code Review Reports
    • development and execution of Test Scripts for: Installation Qualification for core SCADA components, Installation Qualifications specific to each (2) production lines, Operational Qualifications specific to each (2) production lines
    • Production Support Plan
    • Final Validation Reports

The Results

Performance Validation delivered System Risk Assessment and Functional Design Specifications documents that facilitated a clear approach to testing and traceability for the path forward into test script design.

The client was provided with a thorough high-quality qualification testing package that ensured ready traceability to the approved requirements and specifications.

Throughout the validation, Performance Validation positioned themselves to be flexible and responsive to allow the client to optimize their project schedules for successful timing toward meeting pre-production deadlines.

Final Validation Reports were delivered on time and the SCADA system applications were released for production as scheduled.

The Benefits

Performance Validation built upon knowledge and experience gained in serving SCADA system validation projects in the pharmaceutical industry. The application of SCADA technology for medical device assembly differed somewhat from that of pharmaceutical formulation, filling, and packaging, but Performance Validation studied the details of the manufacturing process and was able to able to design a validation package that satisfied the client’s compliance needs.

Performance Validation endeavored to not only meet a minimum set of compliance requirements, but to provide the client a high level of assurance that all aspects of their new SCADA system would function as intended. Careful attention was given to ensuring the resulting life-cycle documentation would be readily maintainable for the life of the system.  Test documentation was designed in a way that provided the client with format and content that with minimum modification could be easily repeated to maintain the validated state of the system under future change control. This medical device manufacturer now has a validated SCADA system which meets their high standards of quality and compliance.

Kevin Marcial,
CSV Services Manager
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile

Ultrasound Validation Project Summary

The Challenge:

A contract research organization (CRO) contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for an ultrasound instrument.  They use the system during surgery to perform analysis flow, stress, wall thickness and detect blockage.  The instrument and its data acquisition/analysis software was purchased to replace an aging ultrasound system that was no longer being supported.  The previous system also saved data to an old tape recording system that would deteriorate and was becoming difficult to buy replacements for.  The lab conducts Good Laboratory Practices (GLP) compliant studies for their clients. To bring the system into GLP compliance, the system required validation. The high demand for surgical studies paired with a short workforce supply contributed to them contracting PV to validate the system in a timely manner to avoid down time.

The following computer system validation project considerations were identified for the client and their commercial-off-the-shelf (COTS) instrument/software:

  • Bringing the system into GLP compliance on an expedited timeline without significant in-house validation procedures or plans implemented
  • Evaluation of 21 CFR Part 11 compliance of the software or the laboratory procedures had not occurred
  • Qualification of the system’s configuration settings to ensure consistent and reproducible results
  • Ensuring the data appropriately stored to a validated cloud storage system for use in study reports
  • Minimizing impact on the stakeholder’s production responsibilities

The PV Advantage:

The PV team on this project had years of experience in GLP laboratory compliance including working on a comparable Ultrasound instrument which contributed to an expedient and comprehensive validation. PV immediately began work prior to being on site to expedite the project launch.  This was followed by onsite support and collaboration with laboratory stakeholders to complete the computer system validation.  The following components detail the PV solution:

  • PV team member was placed on an expedited training regime to become familiar with the system and the validation master plan in place at the facility.
  • Assistance reading/reviewing the SOP in place for the Ultrasound was provided and helped to determine the functionality being used by the client. This collaboration with the laboratory stakeholders helped ensure the timeline remained on track as well as satisfied the applicable regulations.
  • A User Requirements Specification was created by pulling information from the user manual for the software and hardware page-by-page. Then, the requirements were further developed and refined through partnering with the laboratory project stakeholders.  The team focused on the intended use and GLP applicability of the system.  This proved valuable as test script authoring commenced, the stakeholders could either assist in writing tests or delete requirements.
  • Creation of a 21 CFR Part 11 compliance assessment.  PV understood the regulations, the FDA Guidance, and the preamble requirements.  This assessment outlined areas of the software that needed to be addressed with a procedure (i.e. gaps) and was also used to create user requirements. A summary of how the gaps were addressed was also generated to include with the validation package.
  • A Validation Plan was created to outline the planned validation deliverables and the strategy for testing the system. It leveraged the favorable vendor audit and low risk score from ISPE’s GAMP 5 risk and complexity approach evaluation allowed the team to use a risk based approach to maximize efficiency and ensure compliance. This document
  • PV sent a team member to the clients’ site to work on documents and create test scripts. These test scripts were generated as early as possible to give the tester time to practice execution and allow for quality reviews prior to official execution.
  • The PV team member executed some testing and provided guidance and review for the remaining user acceptance scripts to ensure expedient execution.
  • A Requirements Traceability Matrix was created to document where each user requirement was satisfied with testing or vendor documentation.
  • Documentation was created using the clients’ approved forms and comparable formatting preference where applicable.
  • Concerning issues and documentation were shown to the Quality Assurance department to ensure they were appropriately addressed as early as possible to avoid further remediation.
  • PV provided regular project status updates which provided details on the project deliverables, project budget, and risks to the project and schedule.
  • A Validation Summary Report was generated explaining all the validation deliverables and how the clients’ documentation satisfied regulatory requirements.
  • PV provided the client with a “Lessons learned” document to help with future work there and provide insight they specifically asked for after completion of the validation.

The Results:

The lab instrument validation was completed ahead of schedule meeting the customer’s overall system implementation deadlines.  There were a list of observations issued and PV returned to the facility to address and expand testing ensuring all parties involved were satisfied. The validation effort brought the system into compliance with all applicable regulations through excellent documentation standards, testing processes, and a focus on the customer needs.  Business process and regulatory requirements were equally emphasized and constantly considered.

The Benefits:

Performance Validation provided the client computer system validation project execution and consultation through understanding the project, the stakeholders and their needs, and the best fitting validation strategy for a laboratory instrument.  The validation documentation focused on efficiency due to the time constraint and worked with the Information Technology, Quality Assurance, Subject Matter Expert, and Application owner to ensure responsibilities for each document were clearly outlined at every step in the project.  Performance Validation will continue to support the client beyond the system go-live in the event of auditing questions or change controls.


CFR – Code of Federal Regulations Title 21:

Guidance for the Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application:

Kevin Marcial,
CSV Services Manager
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile

Manual to Automated Process Improvement

Clinical Trials Manufacturing – Conversion of a Manual to Automated Process

The Challenge

A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process was needed.

The Solution

Performance Validation provided technical resources with direct experience with automated parenteral packaging processes who provided direct input during the equipment purchase, design, installation, and qualification phases.

  • Performance Validation provided expertise during the commissioning and qualification activities to ensure all necessary documentation was created and all required testing was captured. When faced with the task of qualifying automated vision system measurements and automated inspection processes, Performance Validation was able to implement new, robust test procedures and test reports which captured the accuracy and precision of the vision systems in easy-to-read reports.
  • Performance Validation resources were able to draft the Standard Operating Procedures and Quality Inspection In-Process Testing Procedures to meet the CMO’s needs for process control and product release.
  • Lastly, Performance Validation provided resources to oversee and complete the Performance Qualification phase, which encompassed equipment testing, operator training, new electronic batch record creation, new quality inspection processes, and new procedure approval.

The Benefits

Performance Validation provided a complete documentation package for the entire Design, Installation, Testing, and Maintain lifecycle phases of the equipment and manufacturing process. The automated process has completed system acceptance by the client and has been satisfactorily audited by the CMO’s customers. The documentation package met the customers quality requirements and expectations. The project met the CMO’s ultimate goal of increasing manufacturing volume to meet future anticipated production needs.

For more information about this project or how Performance Validation may assist you with the validation of automation process improvements please contact:

Brad Henry
Vice President and Indiana Division Director
Performance Validation, LLC
5420 W Southern Ave
Suite 100
Indianapolis, Indiana
(317) 248-8848
(317) 727-8495 Mobile