Industry
Healthcare Software Testing Services
In healthcare, validation is held to a standard the rest of the industry is not. A passing suite is the start, not the proof.
Auditors, regulators, and your customers' security reviewers will ask for written proof of what was validated. We make validation provable.
The QASource Intelligent Platform (QASIP) generates the tests. Automation runs the regression. Our engineers know clinical workflows well enough to catch a result that is technically correct and clinically wrong. Every release gets a written record of what was tested and what was found, with the evidence behind it.
QASource provides healthcare software testing services for clinical systems, medical device software, patient-facing applications, laboratory systems, and claims processing.
Passing is not the same as right
A test to update
The product is right. The test is out of date.
Ready to release
It passes every test and is right for care.
Caught by the suite
The result is wrong, and a test flags it.
Technically correct, clinically wrong
Every test passes. A clinician would still see the problem. Our engineers are there to catch it.
Provable, Not Merely Passed
A defect in healthcare software is not a support ticket. It reaches a patient, a diagnosis, or a payment.
That changes what a quality function has to do, most of all for FDA-regulated products and GxP-governed systems.
When the record of what was validated is thin, audits and customer reviews stall. Releases wait while the evidence is assembled after the fact.
Our record is written with every release, not after the fact.
Healthcare Work Needs a Partner That Stays
“QASource played a role in helping us stand up our original engineering teams and get our platform off the ground.”
Twenty-four years, more than 200 companies, and for most of that time, no sales team at all.
We grew by referral.
Technically Correct, Clinically Wrong
This one passed every check it was given. Our engineers caught it because they knew what the result meant for care.
A Patient Portal for Lab Results
A real finding
What the tests saw
The results page showed the patient's full-panel report correctly. Each section showed the right patient's results, and the page loaded without errors.
What a clinician would see
The same page also showed an earlier rapid panel test. It explained two different tests at once, so a physician could not tell which explanation applied.
What it would have reached: A physician unsure which results were the latest, which could delay the right medication or treatment.
A basic test checks what should be on the page. Our engineers also check what shouldn't.
How We Decide What to Test First
Before each release, our engineers decide where testing time goes first. Five signals guide that call. Each one is shown with an example from our work on lab products.
- 01
The Clinical Workflow
What the clinician, lab technician, or patient is trying to do at each step, measured against care, not only against the specification.
In Practice
We test missing results, canceled orders, duplicate records, and regenerated reports, even when no requirement mentions them.
- 02
What a Wrong Result Would Reach
How much harm a wrong result could do.
In Practice
End-to-end order processing, lab results, and report generation come before low-risk UI changes.
- 03
Where It Broke Before
The workflows with a history of defects, and the fixes that didn't hold.
In Practice
Patient and order data mapping broke in earlier releases, so it now has its own regression tests.
- 04
What Changed
The code, the configuration, and every workflow a change touches.
In Practice
A change to lab result processing also gets checks on how results are sent, how reports are built, and what patients see.
- 05
What You Count as Safe to Release
The definition we agree on with you before the first release we test.
In Practice
We review critical results, regression coverage, open defects, risks, and test evidence before the release decision.
Coverage Isn't Trimmed
Regression coverage is never trimmed to make a date.
Untested Work Is Written Down
What we don't reach is recorded as untested, so you know what the release carries. When a system isn't available, we use approved test data or simulated responses and track what's pending.
QASIP Generates, Engineers Verify
The QASource Intelligent Platform (QASIP) generates the tests. Engineers who know your clinical workflows verify every result.
Defects Our Engineers Found Before Release
Each row is one example from an area that gets the most testing before a release.
| Area | What Our Engineers Found | What It Could Have Caused |
|---|---|---|
| New FeaturesThey have had the least testing. | Automatic notes on a lab report conflicted when a patient's samples were tested on different days. | Confusing notes released with no alert. |
| Patient Reports and ResultsPatients and physicians read them directly. | A corrected report for an untested sample said "Negative" instead of "Not applicable." | An untested sample read as a normal result. |
| Critical End-to-End WorkflowsResults can be lost or changed between systems. | A correct lab result was ready, but the notification to the next system was never sent. | A result nobody noticed. |
| PHI and PII ProtectionRequired under HIPAA and ISO 27001. | A staff role without permission could open a lab record editing screen. | Unauthorized staff changing patient lab records. |
What Our Engineers Catch That New Testers Miss
Knowing where to look is not something you staff in a quarter. It comes from understanding how the product works, where it broke before, and what each change touches.
| Where | Where a New Tester Stops | What Our Engineers Also Check |
|---|---|---|
| Lab Orders | That the order is created in Salesforce | That the right patient details, test type, and diagnosis reach the lab |
| Report Downloads | That the report downloads | Whether changing the patient ID in the URL opens another patient's report |
| Portal Results | That lab results reach the patient portal | That the patient and order mapping shows the right results |
| Record Access | Confirms access works as specified | Whether the evidence of those checks is kept for an audit |
| Result Status | A wrong status, logged as a minor UI defect | Whether a result that needs a retest now looks approved |
From our healthcare software QA team
What Your Validation Record Contains
Each release's record is measured against what you count as safe to release. You can hand it to an auditor, a regulator, or a customer's security reviewer.
With Every Release
- The test plan
- What the tests covered
- The defects found, with their evidence
- A test summary
Where You Run a Formal Go/No-Go
- What was tested and what was not
- How each test maps to a requirement
- Release confidence, based on the open issues
- A go or no-go recommendation
Many teams now release each feature or fix as soon as it is ready. Those releases still get the written record, without a formal go/no-go report each time.
Our QA lead on your product gives a go or no-go recommendation with the risks behind it, and your team makes the final call. The engagement is managed by an engineering director.
A real validation record
Validation Record
Background jobs and new billing codes · A build from October 2026
Not safe to release
- Requirements in Scope
-
R1New background jobs run the way they were set up.
R2New healthcare billing codes show up in the application.
- What Was Validated
-
R1We ran the jobs with the planned settings and checked the data they produced.
R1We checked that the system shows an error, instead of failing quietly, when data it needs for matching is missing.
R1 and R2We checked that data moved correctly between two applications.
- What Was Not Validated
-
The reminder email sent after a first contact, and the connections other systems use to send expense entries. The test environment didn't give us access to test them.
- Risk That Remains
-
One critical defect was open: Referrals weren't being assigned to the right nurse or physician under the set rules. One more work item in the release was still in progress.
- Against "Safe to Release"
-
Not met. Wrong referral assignments could delay case processing and treatment and keep patients from timely care.
- Release Recommendation
-
Our QA team sent the "not safe to release" report to the business team. After reviewing it with the developers, they moved the defect and the open work item to the next release.
When a Record Helped in an Audit
When an auditor asks how you know a release was tested, the answer is already on file.
Your product lead or manager reviews the record each release. Multiple healthcare clients have already used our test documentation to support their FDA clearance process. Since the testing was already documented, there was no need to recreate records during audits.
Where We Work in Healthcare
Our healthcare work covers FDA-regulated products and GxP-governed systems. Here is one piece of our work in each area we serve.
Clinical Systems
We tested the full lab order process, from orders created in Salesforce to the lab information system where technicians record results. We checked that the right patient details, test type, and diagnosis reached the lab.
Medical Devices
We tested a patient-monitoring system built on cameras, microphones, speakers, and sensors. We checked video quality, two-way communication, movement and fall detection, and whether safety alerts reached staff on time.
Patient-Facing Applications
We checked that patients could log in securely and view or download their lab reports. Each report had to show the right name, test details, results, and date, matching the original order and lab records.
Laboratory Management
We tested tissue sample tracking at every lab stage, from receiving through processing, quality control, storage, and shipping. Status, chain of custody, and turnaround times had to be right at each one.
Claims
We checked that diagnosis and procedure codes captured on the order flow correctly into billing.
Standards and Interfaces We Test Against
HIPAA
Patient data privacy, security, and access control.
HL7 and FHIR
Healthcare data exchange, from HL7 messages to FHIR APIs.
APIs and Integrations
Data exchange between your applications and outside systems.
LIS and LIMS Interfaces
Laboratory information and sample workflows.
EHR and Patient Systems
Accuracy and interoperability of patient information, where it applies.
End-to-End Workflows
Data integrity, security, and function across integrated systems.
FDA Documentation
Test case and execution records for FDA software validation, in an FDA-accepted format.
21 CFR Part 11
Electronic records, electronic signatures, and audit trails in FDA-regulated systems.
IEC 62304
Software life cycle requirements for medical device software.
Computer System Validation (CSV)
Documented evidence that a GxP-governed system works as intended.
How Patient Data Is Handled in Testing
Patient data is the first thing a security reviewer asks about. Here is how our engineers handle it.
Inside Your Environment
Where required, our engineers work entirely inside your environment, under your access control, and nothing leaves it.
Separated Engagements
Engagements are separated at the network layer, so one environment can't be reached from another.
Synthetic Data Wherever Possible
We don't use PHI unless a test genuinely needs it. We use synthetic or de-identified data wherever possible.
Minimum Necessary
When PHI is needed, we use only the minimum the test requires. Only authorized people with role-based access can see it.
Cleanup and Retention
When testing ends, test data is removed and the environment is cleaned up. Data is kept only as long as the applicable policy allows, then securely disposed of.
Logged Access
Testing activities and data access are logged where the systems support it.
Approved AI Models Only.
Client data is not used to train AI models. Any AI-assisted processing is performed only through approved AI models and services, under appropriate security, access controls, and data protection requirements, in accordance with client agreements.
- ISO 27001:2022
- ISO 9001:2015
- Intertek HIPAA Certificate of Conformance
Our delivery entity in India, bebo Technologies, holds these certificates. You can verify each certificate number yourself, and Fortune 100 companies audit our delivery centers on site.
AI Inside a Clinical Product
More healthcare products now put AI in front of clinicians and patients. The teams that build them need something to show their board, their regulator, and themselves.
How We Validate AI Agents That Fix Member Records
On a health plan product, AI agents find, investigate, correct, and report member records that are missing required links or information. An SDET on our team validates them four ways.
01
Prompts Against the Database
The SDET gives the AI different instructions and checks its answers against the actual records with SQL queries.
02
Known-Answer Data
The AI runs on sample healthcare data where the right results are already known.
03
Automated Checks
Automated tests confirm that the corrections the AI suggests are accurate and don't damage existing records.
04
Real Migrated Data
The AI runs on migrated healthcare data to find errors, verify its corrections, and confirm the whole process works.
For independent evidence on the AI you ship, AI assurance is a separate practice that never validates what we built. Human validation puts trained validators on the behavior a machine can't score.
How a Healthcare Engagement Starts
Testing healthcare software is rarely bought on its own. It is one part of the quality function we build and run for you. You can start with the team or with evidence first.
Start with the team
A Dedicated QA Team Built Around Your Product
The team covers the healthcare application testing described here as one part of your quality function. It works in your tools, your standups, and your release cadence.
- You interview the QA lead before the team starts.
- The team starts within a week of signing.
- The QA lead is your single point of contact.
- Every test is committed to your repository and stays yours.
Start with evidence
An Assessment Before You Commit
You can see our work on your own product before you hand it to a new team. Each assessment ends in a written finding you keep, whether or not you hire us.
Gap Diagnostic
One week
Our engineers review your pipeline, test suite, and release process without changing anything. The two-page finding shows how big the gap is and what it costs in release delays and escaped defects.
Scoped Assessment
Two to three weeks
Our engineers work in your codebase on one service. You get a verified sample suite, a coverage baseline, and a recommended quality model.
AI Assurance Assessment
Three to four weeks
It covers one AI or agentic system in your product. You get an evaluation harness, a ground-truth dataset, the failure modes we observed, and an assurance finding with stated confidence bounds. You keep the harness.
Tell Us Where Your Validation Falls Short
Describe your product, how often you release, and what your auditors ask to see. You'll have a proposal within two business days of our first conversation.
Questions About Healthcare Software Testing
How should a medical software testing company handle our patient data?
Where required, our engineers work entirely inside your environment, under your access control, and nothing leaves it. When a test truly needs PHI, we use the minimum necessary, limit access by role, and clean up the environment when testing ends. Client data is not used to train AI models. Any AI-assisted processing is performed only through approved AI models and services, under appropriate security, access controls, and data protection requirements, in accordance with client agreements. Patient data (PHI) is handled only as permitted under client agreements and applicable healthcare data protection regulations, with synthetic or de-identified data used for testing wherever possible.
What should a validation record include to satisfy an auditor?
It should trace each requirement through test execution and evidence to the risks that remain and the final release approval. It should also say what was not validated. Ours is measured against the definition of "safe to release", we agree with you before the first release we test.
Do you test medical device software and FDA-regulated or GxP systems?
Yes. Our healthcare work covers FDA-regulated products and GxP-governed systems, including clinical systems, medical devices, patient-facing applications, laboratory management, and claims. For FDA-regulated products, we deliver test case and execution documentation in an FDA-accepted format. Our engineers also test against 21 CFR Part 11, IEC 62304, and computer system validation requirements where they apply.
Do you test EHR, HL7, and FHIR integrations?
Yes. Our engineers test HL7 messages, FHIR APIs, and the integrations between your applications and outside systems. In EHR and patient systems, they check that patient information stays accurate wherever it moves.
How do testers catch a result that is technically correct but clinically wrong?
Through engineers who know the clinical workflow well. They see when a result passes its checks but is still wrong for the clinician or the patient.
What does validating AI in regulated healthcare systems involve?
On the products we test, an SDET checks the AI's answers against the real records, using data where the right answers are known. AI assurance, a separate practice, never validates systems we built. In human validation, the validators have usually spent years on the systems they judge.
Can we see engagements like ours before we decide?
Under a signed NDA, we walk you through engagements like yours in detail.
How soon can your team start?
The team typically starts within a week of signing. You interview the QA lead first, and knowledge transfer and access happen in that first week.
Which certificates and audits cover your delivery centers?
ISO 27001:2022 and ISO 9001:2015 certificates are held by bebo Technologies, QASource's delivery entity in India. Anyone can check them by number in the IAF CertSearch public register. The same entity also holds an Intertek HIPAA Certificate of Conformance, and Fortune 100 companies audit our delivery centers on site.