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

稳健医疗

稳健医疗 has integrated eSign.AI electronic signature services into internal business processes, office resolutions, and other scenarios.

華生元

華生元 has adopted eSign.AI services for cross-border online signing and management of business contracts.

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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