Healthcare and Bio-Technology

Testing and Validation Tools for Healthcare & Life Sciences

When developing medical devices or information systems, you need to ensure that the testing and validation procedures meet the requirements of the FDA / EMA and specifically 21 CFR Part 11. Inflectra provides the capability for managing your testing and compliance activities to meet these requirements. We understand your world, our solutions help you develop medical devices, validate patient systems, with electronic signatures.

Compliance Challenges

Whether developing medical devices, managing patient data, or coordinating care, compliance is critical. Life sciences are heavily regulated, and the regulations are constantly changing. You need to perform continuous testing and validation, with real-time traceability.

Tools You Can Trust

Inflectra provides the capability for managing your testing and validation activities to meet these requirements. We have proven turnkey solutions that give you powerful requirements and test traceability, with powerful reporting and workflows that streamline compliance.

Solutions For You, Whatever Your Focus

H for Healthcare

Healthcare

Our tools help healthcare providers and payers manage complex and shifting regulatory and attestation needs; from HIPAA compliance and electronic medical records, to financial traceability and reconciliation.

B for Bio-Technology

Bio-Technology

Move beyond paper-based testing and validation with Inflectra. Whether developing new pharmaceuticals or medical devices, you need FDA-compliant 21 CFR Part 11 traceability and compliance.

L for Life Sciences

Life Sciences

SpiraTest and SpiraTeam give you accurate information and real time reporting. We understand how critical this is for the safety of the public, whether you are running clinical trials or managing public health programs.

Features for Compliance

Validation & Testing

Replace your paper-based methods with streamlined workflows and testing using our integrated validation solution.

Electronic Signatures

Our products include a unique, built-in 21 CFR Part 11 electronic signature facility that is tightly integrated with our customizable workflows to ensure compliance.

Data Privacy

Keep all your project artifacts in a secure, private, HIPAA-compliant repository. Whether you choose cloud hosting, or prefer to install on-premise, we have you covered.

End-to-End Traceability

Use our platform to define your specifications, create test plans and test scenarios, execute tests, and tie corrective actions to the results, with real-time reporting.

Audit Trails

Our platform automatically maintains a secure audit-log of all actions in the system, with the user, timestamp, changes and reason all captured and stored.

Automated Validation

Save time validating your systems. Our platform includes automation tools that generate test scenarios and scripts directly from your running applications.

Trusted By Industry Leaders

Adventist Health System Leica Biosystems National Institutes of Health (NIH) Galderma Medical Solutions

Featured Resources

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Easy To Migrate

You will find it really easy to switch to our platform. You can migrate your legacy data, documents, spreadsheets, and other critical information using our out of the box migration tools.

Free Trials

We encourage you to try our products in your environment. That's why we offer a 30-day free trial (no credit card needed), with all the functionality and our legendary technical support included.

Exceptional Service

Our products come with industry best practices baked in. They have over 70 out of the box integrations, default workflows and industry templates. All products include unlimited world-class technical support.

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