Intertech Engineering Associates, Inc.

Legacy Syringe Pump Software Validation for the Medical Industry

(Click on thumbnail to enlarge)

Legacy Syringe Pump Software Validation for the Medical Industry
Legacy Syringe Pump Software Validation for the Medical Industry

Software validation is a requirement for FDA approval and this project lacked the appropriate validation for FDA approval. This device had been FDA approved and on the market for over a decade. However, due to increased vigilance of the infusion pump industry by the FDA, a recent inspection found that the Design History File (DHF) and validation documentation was inadequate. Intertech Engineering Associates, Inc. was tasked with reviewing the existing documentation and providing a new plan to deal with the gaps in software validation. The software for the Syringe Pump was developed in Assembly Language. The logistics were complex as Intertech had to provide a remediation plan for FDA that allowed the client to continue sales while remediation took place.

The source code was first analyzed using embedded software reverse engineering tools, documenting the software design as its code was re-written and then the system and software requirements were developed. Risk and hazard analysis for the current product, design, and software implementation were performed and documented and from this a software validation plan, test designs, and test procedures, were developed. Design reviews were held at periodic intervals, in addition to conducting validation, as the project progressed. Validation included risk analysis, code inspection, unit testing and requirements verification. Validation test results, test reports, and traceability tables were produced to substantiate test coverage. Finally, in order to meet FDA requirements, a master schedule was delivered along with a requirements design review and meeting minutes, and risk analysis software design documentation including FMEA, SDD and a verification and validation plan. A MPLAB IDE simulator validation summary report was developed along with descriptions of the tests that were carried out, including results, defect reports showing resolutions, a traceability matrix and finally a verification and validation report.

This project was brought to Intertech because the original documentation had been lost or never existed. Intertech successfully helped the client respond to the inspectional finding, reinstating it as an FDA approved product.

Legacy Syringe Pump Software Validation Project Highlights

Project Description
Legacy syringe pump lacked appropriate software validation to comply with FDA expectations. Intertech reviewed the existing documentation, developed a plan to address the software validation gaps, and completed the validation testing and design documentation needed to demonstrate regulatory compliance.
Project Outcome
This validation was completed on schedule, under budget, and was reviewed and deemed acceptable after a re-inspection. Intertech's assistance with remediation planning and implementation saved the client from more severe regulatory actions, and allowed the product to stay on the market during and after remediation.
Type of Project
Software Validation
Tools Used
Multi-Processor Platform
  • PIC controller (8-bit microcontroller PIC16LC64A)
Development Environment
  • Microchip MPLAB IDE
  • Assembly
  • Assembly level interrupt routines
  • Watchdog safety architecture
Other Tools
  • Code inspection techniques
  • MPLAB IDE simulator
  • DOORS – requirements management and traces
  • Visio – software design diagrams
  • Provided remediation plan for FDA to allow client to continue sales while remediation took place
  • Analyzed source code using reverse engineering, and documented the software design
  • Developed system requirements and software requirements
  • Performed and documented risk and hazard analysis for the current product, design, and software implementation
  • Developed software validation plan, test designs, test procedures, held design reviews, and conducted validation
  • Provided validation test results, test report, and traceability tables to substantiate test coverage. Validation included risk analysis, code inspection, unit testing and requirement verification
  • Master schedule
  • Requirements design review and meeting minutes
  • Requirements specification
  • Risk analysis
  • Software FMEA
  • Software Design Document (SDD)
  • Software Verification and Validation plan
  • MPLAB IDE simulator Validation summary report
  • Executed tests and results
  • Resolved defect reports
  • Traceability matrix
  • Final Verification and Validation report
Services Used
  • Embedded software reverse engineering
  • Code inspection
  • Project schedule and tracking
  • Quality (FDA) compliance engineering
  • Requirements development and management,
  • Risk analysis
  • Verification and Validation planning, test development and execution
  • Unit testing and code inspection
  • Design reviews
Processes Used
  • Software engineering
  • Project management
  • Systems engineering
  • Software quality engineering
  • Customer specifications
  • Regulatory compliance: US FDA
Delivery/Turnaround Time
5 months
Product Type
Medication Delivery

View Examples of our Work

Back to Top