We found no public Qualtrics statement of Part 11 compliance. Part 11 is also not a badge: it depends on controls, validation and how you use the system. Here is what to ask and what to check.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Answered in writing
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The short answer
The question
Universities license Qualtrics widely, so it is often the first tool teams reach for when a clinical study needs questionnaires. Then a sponsor, an auditor or a data manager asks the Part 11 question, and nobody has the answer. The honest position is that we cannot tell you Qualtrics is compliant, and we cannot tell you it is not. We found no public Part 11 statement from the vendor. What we can do is show what Part 11 asks of an electronic records system so that you can put exact questions to Qualtrics and judge the replies.
Three framing points help. First, Part 11 applies to records that the rule covers, such as those required by FDA predicate rules; a survey that is not trial data may fall outside it. Second, compliance is not certified by the FDA for software; it is demonstrated through validation and procedures. Third, a tool can be excellent for what it was built for and still be the wrong place for regulated trial records. See 21 CFR Part 11 compliant EDC and the Part 11 compliance checklist.
For the broader choice between tools, Capture vs Qualtrics and REDCap vs Qualtrics set out when a survey platform is enough. If you are already using Qualtrics and want to move, read how to migrate from Qualtrics.
What Part 11 asks
Control areas follow the general structure of 21 CFR Part 11 (system controls in 11.10, signatures in 11.50, 11.70 and 11.200). Put each question to Qualtrics in writing; the Qualtrics column is deliberately blank of claims.
| Control area | What to ask Qualtrics | Capture |
|---|---|---|
| Validation | What validation documentation exists, and who holds the validated state for your use? | Documentation for sponsor validation and UAT is available to enterprise customers; validated use is a shared responsibility |
| Audit trail | Is there a secure, time-stamped trail of changes with old and new values and reasons that cannot be edited? | Field-level, append-only, hash-chained; user, time, old and new value and reason; exportable |
| Access control | How is access limited, and can identifiers be separated from analysis roles? | Role-based access; site coordinators see names, researchers see coded IDs; row-level security |
| Electronic signatures | Are signatures linked to records, with printed name, date and meaning? | Password re-authentication and a legal meaning statement for staff; eConsent with email one-time code |
| Record integrity | Can a form change mid-study without a trace? | Draft and approved states; approved forms locked for live use |
| Retention and export | Can complete records be exported in readable form? | CSV and Excel exports with an automatic data dictionary |
The Qualtrics question column is a worksheet, not a finding. Record the vendor's own written answers.
The Capture sandbox has every feature. Change a value with a reason, sign a form and read the audit trail, with no credit card.
What good looks like
The test is simple: change one value and see what is recorded. A reviewer expects to see who changed it, when, the old and new values and why, and expects that the entry cannot be altered afterwards. Capture records one row per changed field with those details, written by database triggers.
Field
Old value
New value
Reason for change
Changed by
Fit
Qualtrics may be a sensible choice for one-off surveys, formative research, recruitment screening or studies whose records are not covered by Part 11, provided your institution and ethics committee agree. Its strengths are survey design, distribution and analysis. See HIPAA-compliant survey tools for research for what to check on privacy.
It is more likely to fall short when the data support a regulatory decision, when a sponsor expects a validated system, or when the study needs visit schedules, site-entered data, adverse events, randomization or verified consent signatures. In that case use a clinical study platform. Capture is suitable for Phase 1, 2 and 3 and has a free sandbox. It does not work offline, and Part 11 remains a shared responsibility whichever product you choose.
Evaluation checklist
Ask your sponsor, regulatory affairs or ethics contact which records are covered.
Validation, audit trail, signatures and access control, with documents attached.
Edit a value with a reason; export the trail. See audit trail software.
Who writes and holds the evidence. See computer system validation.
Re-authentication and meaning. See electronic signatures for clinical trials.
Export data and a dictionary and archive them with the study documents.
We found no public Qualtrics statement of Part 11 compliance when we searched on 12 October 2026. Ask Qualtrics for written documentation covering validation, audit trail, signatures and access control, and do not assume compliance.
No. Part 11 applies to electronic records and signatures covered by FDA predicate rules. A survey outside a regulated trial may not be covered. Confirm with your sponsor or institution.
Not by the FDA. Compliance is demonstrated through the system's controls, validation and your procedures. Be cautious of badges.
Capture provides Part 11 aligned controls: a field-level audit trail, re-authenticated electronic signatures and role-based access. Compliance is a shared responsibility with the sponsor's validated use.
Only if the records are not covered by Part 11 or your sponsor accepts it after review. For regulated data, use a clinical study platform with validation evidence.
Upload an export of the survey or describe it, review the AI draft, add codes, edit checks and a schedule. See the migration guide.
No. Offline entry is not available today.
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Free, every feature, no credit card. Change a value, sign a form and read the audit trail yourself.