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E-signature

Secure electronic signature for scientific reports with CFR 21 Part 11 and EIDAS compliance, time-stamping, and authenticity certificates.

Solution by Laby
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Overview

Laby's Digital Signature (E-signature) module is a tool for research laboratories to sign and validate scientific reports electronically. It is designed for R&D teams that need to establish the authenticity, precedence, and authorship of discoveries, and to protect innovations through a legally recognised signature process.

The tool is built in accordance with CFR 21 Part 11 and eIDAS requirements, and uses a trusted third-party timestamping service compliant with RFC 3161, as recommended by the European Union. Signatures are secured with an encrypted key, and modification or deletion of signed data is not permitted once a document has been signed.

Key Capabilities

  • Sign scientific reports from any location at any time with a single click
  • Encrypted key attestation confirming the authenticity of information at the date of signature
  • Dual signature process using a trusted third party for automatic time-stamping
  • Compliance with CFR 21 Part 11 and eIDAS standards
  • Certificate of authenticity with legal value generated upon signing
  • Automatic generation of a signature report
  • Data integrity enforced — modification and deletion of signed data is not possible

Submitting and Tracking Signature Requests

  • Add files and reports in PDF format for signature
  • Level 1 and level 2 signing obligations required to obtain a certificate of authenticity
  • Email notifications sent to authorised signatories
  • Reliable process for identifying the signatory

Verification, Signing, and Secure Storage

  • Automatic time-stamping of each signature by a trusted third party
  • Creation of a legally valid certificate of authenticity
  • Automatic signature report generated upon completion
  • Documents stored in a secure area where data cannot be modified or deleted

The Digital Signature module is part of Laby's broader laboratory management platform, which also includes an electronic laboratory notebook, inventory and supply management, equipment and maintenance tracking, scientific bibliography management, timesheet tracking, and production process management. The platform is accessible via demo request and is supported by a contact team reachable by phone and email.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechAcademic / Research
Development stage(s)
Research & DiscoveryPreclinical / Pre-Market
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerResearch ScientistQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11