21 CFR Part 11 ready · Aadhaar-enabled · Globally compliant

Built for the FDA audit. Used everywhere else, too.

Cesign is the digital signature platform engineered for regulated industries — pharma, biotech, medical devices, healthcare. The same audit-grade rigor runs underneath every form you publish, every contract you draft, every document you sign. Forms, CLM, signature, audit — one platform.

Trusted with
Batch records Clinical eConsent SOP approvals CAPA & deviations
· AUDIT-GRADE · · CRYPTOGRAPHIC · · TAMPER-PROOF · · VALIDATION-READY ·
Certified CE
21 CFR · Part 11
The product

One platform.
Four pillars.

Cesign is not four separate products. It is one platform built to handle the full lifecycle of a regulated document — from data capture at the front, through contract drafting and approval, to signature, to audit. One identity model. One audit trail. One user experience.

PILLAR 01

Digital Signature.

Cloud-based signing for everyone — sales contracts, HR documents, vendor agreements. Token-less digital certificates with Aadhaar authentication for India, multi-factor verification globally. Mobile-first.

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PILLAR 02

NoCode Forms.

Collect data that someone has to attest to. Vendor bank account changes, employee emergency records, customer KYC, supplier quality declarations — the form captures the data, the signature captures the accountability. Drag-and-drop designer, web link or QR distribution, API retrieval into your tables.

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PILLAR 03

Contract Lifecycle.

Drafting, redlining, approval routing — and direct flow into signature, with no download-and-reupload. Most CLM tools treat signature as an external integration. We treat it as one continuous workflow.

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PILLAR 04

Regulated Industries.

21 CFR Part 11 compliant. Mandatory 2FA at signing. Mandatory signature reason capture. Cryptographic document linkage. XML audit export. Validation-ready system with IQ/OQ/PQ templates.

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◆ Lead positioning

For organisations where the auditor matters more than the salesperson.

Pharma, biotech, medical devices, CROs, healthcare. Every signature you capture has to satisfy the regulator first — FDA, EMA, CDSCO, MHRA — and the user second. Cesign is built around that ordering. Every rule of 21 CFR Part 11 is mapped to a specific control in the platform.

See how the platform maps to Part 11 →
§ 11.10

Controls for closed systems

Validation, accurate records, ability to generate copies, record protection, system access limited to authorised individuals. Mapped to mandatory 2FA, individually unique accounts, validated onboarding, and TLS 256-bit encryption.

§ 11.30

Controls for open systems

Document encryption and digital signatures for open systems. Mapped to AES-encrypted document storage and cryptographic signature manifestation.

§ 11.50

Signature manifestations

Each signature contains the signer's printed name, the date and time, and the meaning of the signature. Mapped to mandatory signature reason capture, UTC timestamp, IP capture, and tamper-proof manifestation.

§ 11.70

Signature/record linking

Electronic signatures must be linked to their respective records. Mapped to cryptographic signature ID with permanent document linkage — signatures cannot be excised, copied, or transferred to falsify records.

§ 11.100

General requirements for electronic signatures

Each electronic signature must be unique to one individual and cannot be reused or reassigned. Mapped to validated user identity, password complexity, lockout policies, and immutable signature audit trail.

Tamper-proof signature manifestation

Every signature is cryptographically linked to the document.

Signature Manifestation
SIG-ID: 7f3e9a2b-d4c1-4e8f-9b2a
Signer name
Ragunathan Kannan
Email ID
inquire@sathguru.com
UTC timestamp
2026-04-18T14:32:07Z
IP address
203.0.113.47
Reason for signing
Attested — Vendor bank account change request
Cryptographic document linkage
SHA-256: a3f4e8b9...c12d · Bound to FORM-VENDOR-BANK-2026-0428
What you get

One platform, four commitments.

Choose the tier that matches what you sign and what you collect. The platform underneath is the same; the controls and compliance scope flex with the work.

Most signature tools handle the signature.
We handle the audit.

Capability
Mainstream signature tools
Cesign
21 CFR Part 11 mapping
Compliance is "supported" — mapping is the customer's job
Every rule explicitly mapped to a platform control
Signature reason capture
Optional or absent
Mandatory at every signing
CLM → Signature flow
CLM and signature are separate products with handoff via download/reupload
One continuous workflow, no document movement
Attested data collection
Use a separate forms tool, then send a separate signature request
Form fields and signature in one workflow — data and accountability captured together
Audit trail format
PDF report, hard for auditors to ingest
Native XML export, ingest-ready
Validation support
Customer prepares own IQ/OQ/PQ
Validation-ready with templates and auditor login access
Aadhaar digital signature
Not supported
Native, with licensed CCA integration

Sign with the full audit trail
your regulator expects.

Schedule a demo with someone who knows the difference between an electronic signature and a digital one.