Medical Device Software Validation

Traditionally, software validation is one of the most time-consuming and resource-intensive activities a medical device company can undertake. But there’s a faster, easier way to do it.

The FDA requires software validation but doesn’t specify how it should be done. That makes meeting FDA software validation requirements especially challenging. MasterControl Quality Excellence’s patented tools and best practice methodologies help medical device companies cut validation times from months to days.

Free Resources

8 Tips for Compliant and Quick Software Validation

Frequently Asked Questions on Software Validation

Why is software validation done?

MasterControl’s Medical Device Software Validation services

Software validation ensures that software meets the quality standards set by a business and, in medical device industries, the agencies that regulate manufactured products. Validation is required not only for regulatory compliance in the medical device industry, but to serve as evidence of the manufacturer’s commitment to producing safe and effective products.

What is FDA software validation?

Medical device manufacturers are regulated by the Food and Drug Administration (FDA) and are therefore required to validate the electronic systems they use to comply with 21 CFR Part 11 and 21 CFR Part 820, among other regulations. The FDA requires evidence that you've documented how you intend to validate and then to prove that you've done it the way you specified.

How do you validate a software program?

There are six fundamental steps in software validation:

Evaluate software vendors’ development and testing practices.

Define your risk framework.

Establish effective change control.

Stay current with vendors’ upgrade releases.

Leverage – but don’t duplicate – the vendors’ work and documentation.

Perform additional testing, if necessary.

Free Software Validation Resources

Select the free validation resources you’re interested in downloading

Industry Brief: 8 Tips for Compliant and Quick Software Validation
Q&A: FDA Medical Device Investigator Offers Insights on Inspection
Ultimate Guide: The Ultimate Guide to Medical Device Quality Management
White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments

Simplify Medical Device Software Validation

MasterControl’s proven validation methodology significantly reduces the time and effort involved in medical device companies’ validation processes.

MasterControl’s VxT process streamlines validation in the cloud.

The patented Validation Excellence Tool (VxT) drastically cuts testing time and validation burdens.
FDA software validation requires a risk-based approach.

With MasterControl, you can avoid wasting time testing things that don’t affect product quality.
Ensure validation is based on best practices.

We practice risk-based validation according to the latest FDA software validation guidance.
Spend less effort and money on validation.

VxT gives you specifically tailored information based on the MasterControl products you use.
Make validation a sustainable effort.

VxT provides tools and knowledge needed to streamline validation throughout the software life cycle.