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


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


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

Learn More

Try Inflectra Today

Easy To Migrate

It's super easy to switch to our tools. Migrate your legacy data, documents, spreadsheets, and more. (Don't worry, we also have a ton of ways to export your data.)

Free Trials

No credit cards, no contracts, no hassles. You can trial all of our products in the cloud or on your own servers, and all for a generous thirty days.

Service You'll Love

Best practices baked into every product, dozens of integrations, common sense options, first class support every time. That's what our customers love about working with us.

Free Trial Please!

Here are some representative customers:

Customer Name Country
A.Menarini IFR S.r.l. Italy
AIT United States
Alberta College of Pharmacy Canada
Alcon Vision LLC United States
Allergytherapeutics United Kingdom
Alucio United States
American Enterprise Group United States
Aperio United States
AtriCure, Inc. United States
Australian Pharmaceutical Industries Australia
Axon Lab AG Switzerland
Axsana Switzerland
Azenta Life Sciences United States
BIAL - Portela & Cª. S.A. Portugal
BioNTech SE Germany
BioSystems S.A. Spain
Bluedrop Medical Ireland
British Dental Association United Kingdom
Cancer Research UK United Kingdom
CareTech Solutions United States
Carolinas HealthCare Systems, Inc. United States
Celerion United Kingdom
Cellnovo Ltd United Kingdom
Centre for Human Drug Research Netherlands
Cerba Research Belgium
Cleveland Medical Devices Inc. United States
ClinBAY Belgium
Clinisys Belgium
CNWL NHS Foundation Trust United Kingdom
CompuGroup Medical Sweden AB Sweden
Creavo Medical Technologies United Kingdom
csrl MULTIPHARMA Belgium
Cyden United Kingdom
DataForm Software United States
dbMotion Israel
DDI Health Australia
Delta Dental of Colorado United States
Delta Dental of MN United States
DGS Diagnostics Sp. z o. o. Poland
Dialog NT Australia
DiaMed Australia Australia
Diatron MI Zrt Hungary
Distributed Medical AB Sweden
Docobo Ltd United Kingdom
Erne Consulting AG Switzerland
Evolvent United States
Galderma SA Switzerland
GalvoSurge Dental AG Switzerland
GDIT Health United States
Global Strategies United States
Globus Medical United States
Great Lakes Neurotechnologies United States
GroupCare Technologies United States
guideVue, Inc. United States
Gyros AB Sweden
Health Service Alliance S.A. Chile
Healthcare IT, Inc. United States
Het Roessingh Netherlands
hVIVO Services Limited United Kingdom
iCardiac Technologies United States
Imatis AS Norway
INFERMED LTD United Kingdom
INFINITT Healthcare Republic of Korea
Interacoustics A/S Denmark
Intermountain Healthcare United States
IntraMed A/S Denmark
iSono Health United States
King Abdullah International Medical Research Cente Saudi Arabia
Labcorp Endpoint Clinical Inc. United States
Legrand Group España, S.L. Spain
Leica Biosystems Germany
Leica Biosystems Imaging Inc. United States
LUKS Switzerland
LumiradxCareSolutions United Kingdom
Maico Diagnostic GmbH Germany
McKesson United States
Medavie Blue Cross Canada
Medical Decision Network, LLC United States
MedImpact Healthcare Systems, Inc. United States
medisite Systemhaus GmbH Germany
Medisupport Switzerland
Medvoxel Systems United States
MeVis Medical Solutions AG Germany
Mikroscan Technologies Inc. United States United States
Molecular Biometrics, Inc. United States
MRS, Inc. United States
NederCare B.V. Netherlands
Neurostar Solutions United States
Newcross Healthcare Solutions Ltd United Kingdom
Noventi Health SE Germany
NOxBOX Limited United Kingdom
Numares AG Germany
NutriSystem Inc. United States
Oehm und Rehbein GmbH Germany
Oehm und Rehbein GmbH - EVAL Germany
Omnicomm, Ltd United Kingdom
Osler Diagnostics Limited United Kingdom
Oxford BioMedica United Kingdom
Palogic Solutions, LLC United States
Pfizer United States
Pharma Quality Europe srl Italy
Physicians Interactive United States
Physicians Interactive India
Pie Medical Imaging Netherlands
Preventive Medicine United States
pro-ficiency United States
Propria United States
Rocky Mountain Health Plans United States
Rogan-Delft Netherlands
Rogan-Delft - Evaluation Netherlands
Roxall Spain
Royal Marsden Hospital United Kingdom
RxScan, Ltd. United States
Sapient GS NIH United States
Saskatchewan Cancer Agency Canada
SMART Management, Inc. United States
Softov Medical Systems LTD Israel
Sotio Biotech a.s. Czechia
St Elizabeth United States
State of Vermont United States
Suomen Lääkedata Oy Finland
Surgical Information Systems United States
Telemis SA Belgium
Telstra Health Emerging Systems Australia
umlaut telehealthcare GmbH Germany
University of Utah Health Care United States
USDM Life Sciences United States
Vaxcare United States
Versagenics, Inc. United States
Vision RT Ltd United Kingdom
WebOps, LLC United States
Wingspan an IQVIA Company United States
Zelis Healthcare United States
Zethon Ltd United Kingdom