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.
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.
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.
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.
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.
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.
Replace your paper-based methods with streamlined workflows and testing using our integrated validation solution.
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.
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.
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.
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.
Save time validating your systems. Our platform includes automation tools that generate test scenarios and scripts directly from your running applications.
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.
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.
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.