An electronic signature, or eSignature, is an electronic indication of intent to agree to or approve the contents of a document. Implemented correctly, electronic signatures are the legal equivalent of written signatures and may be used to effectively manage transactions within an organization and to collaborate with partners such as CROs, customers and suppliers. In addition to being faster and more efficient than traditional written signatures, electronic signatures are secure, encrypted, tamper-evident, and include an extensive audit trail. Electronic signatures may be implemented to benefit all parts of the product development cycle - including clinical trial management, regulatory affairs, research laboratories and manufacturing.
An Integrated Compliance Solution
By partnering with DocuSign, ComplianceLogix delivers the most trusted and widely used electronic signatures from the global leader of Digital Transaction Management (DTM) solutions. DocuSign supports life science organizations’ compliance with the e-signature practices set forth in 21 CFR Part 11 with tailored functionality and packaged service offerings. DocuSign’s open, standards-based approach makes it easy to integrate electronic signatures in accordance with Part 11 requirements, even into complex processes and systems.
Life science organizations can benefit from a fully digital transaction while maintaining compliance with 21 CFR Part 11 standards in a systematic and consistent manner. DocuSign’s DTM platform is ISO 27001 and SSAE 16 certified, enables mobile transactions on any device, and utilizes a Carrier Grade architecture which allows continuous availability.
With ComplianceLogix, life science organizations can use DocuSign to reduce cycle times for reviews and approvals while ensuring that electronic signatures meet Part 11 requirements and are legally binding. All documents and data are encrypted in transit and at rest and each transaction includes a fully traceable, tamper-proof audit trail and exportable Certificate of Completion.
Utilize electronic signatures to streamline your work in use cases such as:
- Batch records
- Investigator approvals
- Patient consents
- Quality document approvals
- Supplier agreements