For pharma, biotech, medical devices, CROs, and healthcare. Every rule of 21 CFR Part 11 mapped to a specific platform control. Validation-ready system with IQ/OQ/PQ templates. Auditor-grade audit trail in XML. Built for batch records, clinical eConsent, SOP approvals, CAPA, and deviations.
Regulated industries do not buy electronic signature software the way other industries do. The buyer is not a sales operations leader, it is a validation manager. The decision criterion is not "does it improve our cycle time," it is "will it satisfy our auditors and our regulators." The rejection criterion is not "the price is too high," it is "your audit trail will not hold up."
Cesign was engineered against that reality. Every rule of 21 CFR Part 11 is mapped to a specific control in the platform. Auditors are given login access to inspect controls directly. Validation packages include IQ/OQ/PQ templates with full test traceability. The audit trail is exported in XML for direct ingest into the customer's compliance system. None of this is bolted on. It is the architecture.
Each subsection of Part 11 has a specific implementation in Cesign. Not "we support compliance" — specific controls, specifically mapped, specifically auditable.
Validation, accurate records, ability to generate copies, record protection, system access limited to authorised individuals.
How Cesign maps: Mandatory 2FA on every login. Individually unique user accounts that cannot be shared or reassigned. Validated onboarding with identity verification. TLS 256-bit encryption in transit; AES encryption at rest. Configurable password complexity, expiry, and account lockout policies.
Document encryption and digital signatures sufficient to ensure record authenticity, integrity, and confidentiality from creation through receipt.
How Cesign maps: AES-encrypted document storage. Cryptographic signature manifestation that binds the signature to the document hash. Open-system encryption applied at upload, validated at retrieval, retained for the document lifetime.
Each signature contains the printed name of the signer, the date and time of signing, and the meaning of the signature.
How Cesign maps: Mandatory capture of signer name, UTC timestamp, IP address, email ID. Mandatory signature reason at every signing — the signer must explicitly state why they are signing, supporting legal intent. Tamper-proof manifestation visible in the document and in the audit trail.
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify a record.
How Cesign maps: Cryptographic signature ID with permanent document linkage. Each signature is bound to the SHA-256 hash of the specific document. Excising, copying, or transferring the signature to another document is mathematically detectable; the linkage breaks if anything in the bound record changes.
Each electronic signature must be unique to one individual and shall not be reused or reassigned. The organisation must verify the identity of the individual.
How Cesign maps: Individually unique user accounts (cannot be shared, cannot be transferred to another person). Validated signer onboarding with documented identity verification. Password re-authentication required at every signing event. Immutable audit trail of every signature against every user.
Six industries where the auditor and the regulator are the primary stakeholders — not the salesperson or the buyer. Cesign was designed against the rules these industries operate under.
Batch records, QA release authorisations, change controls, deviation investigations, CAPA approvals, GMP policy acceptance, validation protocol sign-off, supplier quality declarations.
Design history files, design controls sign-off, regulatory submission attestations, software validation records, complaint investigations, MDR/MDD compliance documents.
Patient eConsent, protocol sign-offs, investigator certifications, study log attestations, sponsor approvals, monitoring visit reports, GCP training acknowledgements.
Patient consent forms, medical record updates, HIPAA acknowledgements, prescription authorisations, lab result sign-offs, treatment protocol approvals.
HACCP plan attestations, supplier compliance declarations, food safety audits, recall procedures, allergen control documentation, regulatory filings.
Product registration submissions, ingredient compliance attestations, GMP records, label approvals, claims substantiation, adverse event reporting.
The specifics that matter when your validation team is reviewing the platform for use in a GxP-regulated environment.
Every signing event requires the signer to re-enter their password, on top of standard 2FA login. The act of signing is authenticated independently from the act of being logged in.
Every signature requires the signer to state explicitly why they are signing. Approval, review, witness, authorisation. The reason is bound to the signature and visible in the audit trail.
Installation Qualification, Operational Qualification, Performance Qualification templates included. Auditor login access for direct inspection of controls.
Audit trail exported in XML format for direct ingest into your compliance system or e-clinical platform. Not a PDF report. Auditor-ingest-ready.
Configure sequential workflows for QA release, hybrid for CAPA approvals, parallel for documentation review. Workflow chains are themselves audit-trailed.
Once signed, records cannot be edited. Once a period closes, records cannot be unlocked without an approved exception logged in the audit trail.
Schedule a demo with someone who can walk through the Part 11 mapping and the validation package in detail.