Stop wrestling with tools that weren't built for you.
Clinical teams shouldn't have to force-fit a commercial eSignature tool into a regulated world. Capque eSign does one thing well: getting trial documents signed compliantly, quickly, and without the complexity. FDA and EMA compliant from your very first envelope.
Free plan · 3 envelopes a month · No credit card · No IT ticket
Every signature: sealed, timestamped, inspector-ready. §11.10(e)
Up and running today
Sign up, upload, add signers, send. Your first compliant workflow takes minutes — not a procurement cycle or an IT ticket.
No IT requiredCompliance isn't a paywall
Full 21 CFR Part 11 and EMA Annex 11 compliance on every plan — including the free one. We don't put regulatory features behind pricing tiers.
Every plan, day oneProof your QA team will love
MFA-verified identity at signing, cryptographically sealed records, and audit exports ready in one click — not one afternoon.
§11.70 · §11.200 · Annex 11 §12Upload your document
Protocols, site agreements, amendments. PDF and Word supported.
Add your signers
Who signs, in what order, with a deadline. Drag, drop, done.
Signers verify and sign
MFA-verified identity at the point of signature — exactly as Part 11 and Annex 11 require.
Your audit trail is ready
Tamper-proof, complete, exportable in one click for inspectors or your eTMF.
Global regulatory compliance
Compliance your QA team can verify.
Not just read about.
FDA, EMA, MHRA, ICH — your trials don't stop at borders, and your compliance shouldn't either. Ask us for the evidence behind any claim below. If we can't produce it, don't buy the platform.
Built around Part 11 from day one
§11.10(e) tamper-evident audit trail on every envelope. §11.50 signature manifestation — printed name, date/time, and meaning of signature on the record itself. §11.70 signatures cryptographically bound to their documents. §11.100 identity verification before credentials are issued. §11.200 multi-factor authentication at the point of signature.
Ready for EU trials from day one
Access control, audit trail, and data integrity requirements addressed in one platform — so US and EU studies don't mean two compliance headaches. Enterprise plans include MHRA submission support.
A clear answer for your QA team
Developed consistent with ISPE GAMP 5 risk-based principles, and ready for ICH E6(R3) expectations around electronic systems. Formal validation documentation is available on request — just ask.
Independently audited
Annual SOC 2 Type II audit with a 12-month observation period. Full report available to enterprise customers under NDA. We show the evidence, not a badge.
Full compliance starts on the free plan.
Every plan — including the $0 one — gives you complete 21 CFR Part 11 and EMA Annex 11 compliant workflows, full audit trails, and MFA at signing. Regulatory features are never the upsell.
Head-to-head
The table every QA director builds before choosing a platform.
General-purpose tools can be configured toward compliance — but the validation burden, the configuration risk, and the audit response stay on your desk. Here's the honest comparison, citations attached. Verify every row against your own requirements.
| Requirement | Capque eSign | Other eSign tools | Wet signatures |
|---|---|---|---|
| 21 CFR Part 11 compliant workflows | Yes — every plan, out of the box | Partial — customer-configured via compliance add-on | No — N/A |
| EMA Annex 11 (EU trials) | Yes — addressed in the same platform | Partial — customer-configured and documented | Partial — paper processes, manual controls |
| §11.10(e) audit trail | Yes — tamper-evident, every envelope | Partial — available; retention configurable by admin | Partial — paper log, alterable |
| §11.50 signature manifestation | Yes — enforced on every record | Partial — depends on envelope configuration | Partial — handwritten, unverifiable |
| §11.70 cryptographic record sealing | Yes — sealed on signing, chain of custody | Partial — certificate-based, config-dependent | No — physical only |
| §11.200 MFA at signing | Yes — every signing event, every plan | Partial — optional setting | No — none |
| SOC 2 Type II | Yes | Yes | No — N/A |
| Compliance on the entry-level plan | Yes — free plan included | Partial — compliance modules are typically enterprise-tier | No — N/A |
| Validation documentation | Yes — available on request, GAMP 5 aligned | Partial — templates; customer authors and owns | No — N/A |
| Time to first compliant signature | Yes — minutes; enterprise live within a week | Partial — weeks–months of configuration | Partial — immediate but non-compliant for e-records |
| Built for clinical trials | Yes — only thing it does | Partial — general-purpose, adapted | Partial — predates the question |
"Other eSign tools" reflects general-purpose eSignature platforms with life-sciences or compliance add-on modules, based on publicly available vendor documentation as of [DATE — REPLACE_BEFORE_LAUNCH]. Capabilities vary by vendor, plan, and configuration. ▲ indicates capability typically exists but compliance responsibility rests with the customer. Verify against your own requirements.
The platform
Built for the job. Not adapted for it.
Every feature exists because clinical teams asked for it — or because a regulation required it.
Batch records
Signer sequence enforced across production and QA review, with full manifestation data — name, timestamp, signature meaning — on the record itself.
SOP approvals
Route approvals through authorship, quality review, and effective-date release. Superseded versions stay locked and audit-linked to their successors.
CAPA sign-offs
Closure requires the designated quality role — out-of-role signatures are structurally blocked. Every stage transition lands in the audit trail.
Protocol approvals
Sponsor, investigator, and IRB-facing chains with delegated-authority tracking. Amendment signatures seal to the exact protocol version they approve.
Audit response packages
Export any record set with its complete audit trail and certificate of completion in minutes. Ready before the inspector asks.
Deviations & investigations
Investigation reviews follow your escalation matrix. Unresolved deviations can't be closed without the required quality unit signature.
Fits into how you already work
Designed to work alongside your existing clinical workflows. Deeper native connectors are on the roadmap — tell us which one you need first.
Pricing
Start with what you need. Grow when you're ready.
Every plan — including the free one — gives you full 21 CFR Part 11 and EMA Annex 11 compliant workflows. We don't put regulatory features behind a paywall.
Free
$0/mo
See it for yourself. No commitment, no card.
3 envelopes / month- 21 CFR Part 11 compliant workflows
- Full audit trail on every document
- Multi-factor authentication
- Email notifications & reminders
- Email support
Standard
$19.99/user/mo
For teams running active studies.
25 envelopes / user / month- Everything in Free
- EMA Annex 11 aligned workflows
- Validation documentation on request
- Priority support
Enterprise
Custom
For sponsors, CROs, and global site networks.
Unlimited envelopes- Everything in Standard
- Unlimited users & envelopes
- SSO / SAML integration
- Custom data residency (US, EU, APAC)
- MHRA submission support
- Dedicated Customer Success Manager
- Onsite training & validation support
- SLA-backed uptime · custom BAA and MSA
All plans include a full audit trail and Part 11 compliant workflows. Pay annually and get 2 months free.
From the field
What teams like yours are saying
"We'd put off our eSign rollout for months. Other tools always felt like too much effort in a regulated environment. With Capque eSign, our QA team was satisfied within days. I didn't expect it to be that straightforward."
"US and EU trials used to mean two compliance headaches. One platform covering both FDA and EMA has made our eTMF cleaner, and our inspections far less stressful."
"40 sites across 12 countries. Keeping signature workflows consistent used to be a constant fire. Now it's just not a problem."
FAQ
Questions we hear a lot
If something isn't answered here, just reach out — we respond quickly.
Is Capque eSign genuinely 21 CFR Part 11 compliant, or just marketing?
How does it handle EMA Annex 11?
What exactly is an "envelope"?
How long does it take to get started?
Does it support electronic Informed Consent (eICF)?
We have a large global site network. How does pricing work?
Your next document is waiting to be signed.
Start free today. No lengthy setup. No IT ticket. Just compliant signatures, from the very first one.