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 can help you with your testing and validation challenges. SpiraTest, our requirements and test validation solution provides makes the validation of specification and testing procedures easier than the traditional methods.
With SpiraTest you have the real-time evidence that your requirements have 100% test coverage and that your testing activities have all been performed in accordance with your test and validation plan.
When you define the specifications for your product in SpiraTest using the requirements module, you can tie the test scenarios, test results, defects and corrective actions to these source specifications. This end-to-end traceability allows you to prove that all of the required features have been fully tested and that all required test scenarios have been executed, and that all reported defects have been corrected.
For many organizations doing validation, one of the biggest challenges is the lack of time and resources to write test cases for all the systems and tools already in use. Our Rapise automated test validation system includes a powerful feature that lets you create your test cases automatically by just using the application that needs validation:
SpiraTest securely and automatically stores any and all field changes to artifacts (e.g. requirements, test cases, test steps) in the system. The Audit Trail includes the field's old value, new value, name of the user who made the change, and date and time. These records can then be printed out along with the artifact through the reports center.
In addition, when you enable electronic signature support, the changes are signed by the user and any tampering will be detected by the system, invalidating the change.
SpiraTest's robust security model ensures that your specifications, test scenarios, test results and certification data have the highest security. Information access is controlled by a username, password with roles and permissions controlled on a per-project, per-artifact basis.
SpiraTest can be secured using SSL technology to ensure that all the data is encrypted when travelling over your network.
When developing software, systems and hardware for use in medical devices, healthcare IT systems or pharmaceutical processes, you need to follow a requirements and quality management process that complies with the FDA Title 21 CFR Part 11 set of Federal Regulations SpiraTest provides out of the box support for electronic signatures as specified in 21 CFR Part 11 with the ability to require electronic signatures on a per-workflow basis:
SpiraTest provides the following security features in accordance with FDA requirements: authentication required to access any part of the system, closed system, and administrator access level can be defined to set up security.
SpiraTest provides the following workflow features in accordance with FDA requirements: records can be displayed on screen, in reports, electronically, or exported into a flat file format, specific events in the workflow can be forced to require a comment or certain fields be set, full audit trail of all changes made to artifacts in the system:
It is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical elements of a compliant system.
At Inflectra, we believe that SpiraTest contains the required technical elements for a compliant system, however it is up to each customer to verify that their implementation of SpiraTest meets their certification needs as part of their overall quality assurance process.
|A.Menarini IFR S.r.l.||Italy|
|Adventist Health Systems – AIT||United States|
|AtriCure, Inc.||United States|
|Australian Pharmaceutical Industries||Australia|
|Axon Lab AG||Switzerland|
|BIAL - Portela & Cª. S.A.||Portugal|
|British Dental Association||United Kingdom|
|Cancer Research UK||United Kingdom|
|CareTech Solutions||United States|
|Carolinas HealthCare Systems, Inc.||United States|
|Cellnovo Ltd||United Kingdom|
|Cleveland Medical Devices Inc.||United States|
|CNWL NHS Foundation Trust||United Kingdom|
|CompuGroup Medical Sweden AB||Sweden|
|DataForm Software||United States|
|Delta Dental of Colorado||United States|
|Dialog IT – Health||Australia|
|Diatron MI Zrt||Hungary|
|Docobo Ltd||United Kingdom|
|Erne Consulting AG||Switzerland|
|GalvoSurge Dental AG||Switzerland|
|Great Lakes Neurotechnologies||United States|
|GroupCare Technologies||United States|
|Grupo Neat S.L.||Spain|
|guideVue, Inc.||United States|
|Health Service Alliance S.A.||Chile|
|Healthcare IT, Inc.||United States|
|HUNTERDON MEDICAL CENTER||United States|
|hVIVO Services Limited||United Kingdom|
|iCardiac Technologies||United States|
|INFERMED LTD||United Kingdom|
|INFINITT Healthcare||Republic of Korea|
|King Abdullah International Medical Research Cente||Saudi Arabia|
|Medavie Blue Cross||Canada|
|Medical Decision Network, LLC||United States|
|medisite Systemhaus GmbH||Germany|
|Medvoxel Systems||United States|
|MeVis Medical Solutions AG||Germany|
|Mikroscan Technologies Inc.||United States|
|Molecular Biometrics, Inc.||United States|
|MRS, Inc.||United States|
|Neurostar Solutions||United States|
|Newcross Healthcare Solutions Ltd||United Kingdom|
|NutriSystem Inc.||United States|
|Oehm und Rehbein GmbH||Germany|
|Omnicomm, Ltd||United Kingdom|
|Physicians Interactive||United States|
|Preventive Medicine||United States|
|Rocky Mountain Health Plans||United States|
|Royal Marsden Hospital||United Kingdom|
|RxScan, Ltd.||United States|
|Sapient GS NIH||United States|
|Softov Medical Systems LTD||Israel|
|Suomen Lääkedata Oy||Finland|
|Surgical Information Systems||United States|
|TrueVision Systems, Inc||United States|
|University of Utah Health Care||United States|
|Versagenics, Inc.||United States|
|Vision RT Ltd||United Kingdom|
|Wingspan Technology, Inc.||United States|