Validation Of Software Tools In Medical Device Development
Jeff Skinner, Vice President of Engineering

There are two general areas where commercial software is used: manufacturing and product development.  Manufacturing processes and equipment frequently use software as part of their operation, and product development engineering often relies heavily on software- based development tools 

The FDA guidance document titled “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” gives the following scope (see references below):

• Applicability
• Software used as a component, part, or accessory of a medical device
• Software that is itself a medical device (e.g., blood establishment software)
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment)
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record)
• Audience
• Persons subject to the medical device quality system regulation
• Persons responsible for the design, development, or production of medical device software
• Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself
• FDA Investigators
• FDA Compliance Officers
• FDA Scientific Reviewers

As a qualified medical device manufacturer, ControlTek has implemented procedures for validating software tools used both in engineering and manufacturing.  This validation process is risk driven; we start by analyzing the risks associated with a given tool, and focus the validation to address the risks.  In this process, we understand that the risks are not the same in every company or in every engineering project.

As part of ControlTek’s engineering project process, suitable development tools are selected.  The tools must be tested to validate their suitability for the engineering project.  This ensures that the tools selected provide expected design outputs. 

ControlTek’s manufacturing process includes process equipment, inventory and document management, and quality systems that depend on computer systems.  These systems must be validated to insure that they provide the intended results.

All validation plans begin with an assessment of risks involved in using the software or equipment or performing a process.  Identified risks are used to establish suitable protocols that will test for ControlTek’s specific applications and environment.  The validation plan must identify the applicable controls that ensure the process, equipment or use of software is effective.

Appropriate managers review the validation plans and testing results to ensure thoroughness in the validation process.

References

• FDA software validation guidelines:  http://www.fda.gov/cdrh/comp/guidance/938.html
• Guidance for off-the-shelf (OTS) software validation: http://www.fda.gov/cdrh/ode/guidance/585.html
• Process Validation: http://www.fda.gov/cder/guidance/pv.htm

Risk Management: ISO 14971 Medical devices – Application of risk management to medical devices may be a useful reference for identifying risks, however its application is intended for medical device design and is used for ControlTek’s engineering process when doing design work for medical device customers.