Food and Pharmaceutical Electronic Signature Solution

Customer Pain Points

Clinical trials, batch production, and quality inspections involve sponsors, research sites, ethics committees, operators, and suppliers. Informed-consent forms, batch records, and quality agreements need to retain signer identity, signing time, action records, and version changes together. eSign.AI provides electronic signatures that meet GxP and CFR 21 Part 11 requirements, along with standardized signing workflows, audit trails, and identity verification to help keep document versions controlled and support regulatory reviews.

Use Cases

Supports the signing of key documents for clinical trials, pharmaceutical production and inspection, and supplier management.

Clinical trial document signing: Sponsors, research centers, and ethics committees can sign clinical trial agreements, investigator brochures, informed consent forms, and other documents online while maintaining standardized processes and controlled document versions.

Batch production and inspection records: After identity verification, operators and quality inspectors can electronically sign key GMP documents, such as pharmaceutical batch production records and batch inspection records. The system associates each action with its execution time and operational context.

Supplier and quality agreements: Companies can sign and archive procurement and supply cooperation agreements, quality agreements, and technical documents online with suppliers of active pharmaceutical ingredients, excipients, and packaging materials.

Key Features

FDA-Compliant Electronic Signatures

Signing task settings can be customized based on business needs. Support for FDA-compliant electronic signatures, batch signing, scheduled signing, automatic signing, and signing at designated locations helps meet the operational workflow requirements of different signing scenarios and documents.

e-KYC Identity Verification

Integrates with trusted identity verification services in multiple countries and supports identity document and holder verification as well as CA database comparison and authentication. These capabilities help verify the security and authenticity of signer identities and reduce the risks of unauthorized signing and business contract breaches.

Open Services

Provides open API services and webhook push capabilities that can be integrated with customer business systems to support document generation, routing, signing, and archiving across each stage while maintaining data continuity between systems.

Customer Stories

Life sciences companies sign board resolutions, test reports, and authorisation letters that involve overseas individuals and regulated records. Three deployments show how those documents move online without losing traceability.

Winner Medical

Winner Medical moved board resolution signing after its overseas acquisition online, removing the time consumed by cross-border paper circulation and centralised offline signing. Resolutions now form clearer electronic records from initiation to retention, so governance matters stay traceable while the board, legal, and management teams confirm decisions faster.

HaoYang Biotechnology

HaoYang Biotechnology moved test report and authorisation letter signing online, so documents involving overseas individuals no longer depend on international mail. Domestic and overseas signers use the same electronic process, removing the inconsistency that appears when jurisdictions run at different paper speeds and keeping documentation in step with research milestones.

RuiPu Genetic

RuiPu Genetic moved quality review agreements with overseas individuals online so authorisation is obtained without international mail. Full authorisation is captured inside the signing flow, giving a record of who authorised what and when, rather than reconstructing it from returned paper for documents tied to precision diagnostics and genetic screening.

Regulatory framework for regulated industries

FDA 21 CFR Part 11

In the US, electronic records and signatures used in FDA-regulated activities must meet 21 CFR Part 11: validated systems, unique user IDs, secure signer authentication, and linked electronic signatures that record the signer's identity and intent.

GxP record integrity

Clinical trials, batch records, and quality documents fall under GxP expectations. The electronic signature workflow should preserve the integrity of the record — version control, audit history, and the ability to reconstruct the signed record years later.

ALCOA+ principles

Regulators expect data to be attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available. Configure signing workflows so each record carries the signer, timestamp, and action automatically.

21 CFR Part 11 vs eIDAS vs other regimes

Outside the US, eIDAS (EU), PIPEDA (Canada), and other frameworks govern electronic signatures differently. A system configured for Part 11 compliance is not automatically compliant elsewhere — validate against each applicable regime.

Validating an e-signature workflow for life sciences

Classify records and systems

Identify which records are regulated (clinical, manufacturing, quality) and whether the signing system is part of a validated computer system. This determines the evidence and validation documentation you need.

Map signer roles and permissions

Define who may sign, approve, and review each record type, with unique user accounts and access controls that satisfy Part 11's user-identification requirements.

Configure the audit trail

Ensure the platform records every action — view, edit, send, sign, reject — with user, timestamp, and reason where required. Verify the audit trail is tamper-evident and exportable.

Document and re-validate

Keep validation documentation for the configured workflow, and re-validate when the platform version, document templates, or regulated processes change.

Frequently Asked Questions

Supported documents include clinical trial agreements, investigator brochures, informed consent forms, pharmaceutical batch production records, batch inspection records, procurement and supply cooperation agreements, quality agreements, and technical documents. Participants include sponsors, research centers, ethics committees, operators, quality inspectors, and suppliers of active pharmaceutical ingredients, excipients, and packaging materials.

Team discussing the right eSignature approach for a business

Explore the right eSignature approach for your business

Talk to our team about eSignature requirements, compliance considerations, and document workflows across your target markets.

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