Is Your Quality Management Software FDA Validated?

Is your quality management software FDA validated for use in the medical device industry?

Given the importance of FDA compliance for healthcare organizations, it never surprises us to hear this question. Quality leaders understand the need to conform to FDA standards from end to end, so it makes sense that this is a frequently asked question.

But the answer is no—software vendors cannot currently obtain FDA validation, as the FDA requires the purchaser to validate the software based on its intended use within the broader context of the quality system or production environment. According to the FDA’s Code of Federal Regulations Title 21 Part 820.70(i):

“When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.”

Even though the FDA validation responsibility belongs to the software purchaser, ARMATURE can facilitate your validation efforts by providing information about our software testing procedures and security measures when needed.

ARMATURE’s Internal Validation Process

We put our quality management software through a rigorous internal validation process to ensure it meets your every requirement and satisfies our high standards of excellence, and we extend that care to our hosting environment.

Our continuous integration process includes code analysis and automated regression testing (such as unit testing, integration testing, end-to-end testing, and REST API testing) supported by our functional testers who are experienced in the domain. On the hosting side, we focus on penetration testing, intrusion prevention, and SOC2 compliance.

And we don’t stop once we release the product to you. Our product team is always hard at work building new features, fixing bugs, and managing patches. When you invest in ARMATURE’s out-of-the-box quality management solution, you’ll benefit from the white glove service and regular upgrades that keep your organization ahead of the regulatory curve.

Our Roots in Standards & Compliance

ARMATURE knows standards and compliance from the inside out. For 16+ years, we have been building quality management software solutions to support organizations in the education, healthcare, manufacturing, and laboratory industries. What makes us different from many of our competitors is that we have worked directly with Standards Development Organizations (SDOs) and Conformity Assessment Bodies (CABs)—and many of our customers fill both roles.

This intimate understanding of standards and compliance from both sides is reflected in our powerful and intuitive software. Organizations build their audits and processes around the industry standards that matter to them, all within our system. They then collect data that demonstrates compliance—or alerts them to non-conformances and quality issues that need to be addressed. Using ARMATURE’s quality management software, it’s easy to stay on top of FDA standards and other industry regulations, even as they change over time.

With ARMATURE, You’ll Always Be Prepared for Any Audit

One of the many perks of our quality management software is that collects and contains your critical quality data and documentation, so you’ll never have to go hunting through email threads and paper artifacts to demonstrate compliance.

If the FDA decides to audit your organization, everything they need to see will be in your ARMATURE system. Housing your quality data in a separate system like ours is ideal, because you can hand over the keys to the auditors when you need to, without giving them visibility into your entire organization.

If you have any questions about our software validation process, please contact us—we’d love to answer any questions you have. Or better still, schedule a demo to see our quality management software in action!

 

 

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