Viedoc eSignature

Regulatory-compliant electronic signature collection for clinical trials, with 21 CFR Part 11 compliance and complete audit trails.

Solution by Viedoc

Overview

Viedoc eSignature is a digital signature solution designed for clinical trials, embedded within Viedoc's eClinical suite. It supports the regulatory-compliant collection and sharing of electronic signatures, including facilitating informed consent by allowing study participants to sign documents on their own devices. The solution is fully compliant with 21 CFR Part 11 and maintains complete audit trails.

The tool is intended for clinical research organizations, sponsors, and site personnel who need a secure, compliant method for capturing signatures across decentralized, hybrid, or traditional trial settings.

Key Features

Full compliance with 21 CFR Part 11 regulatory requirements for electronic signatures
Complete audit trails to support internal oversight and external regulatory audits
Strict access controls to protect participant and site personnel privacy
Participants can sign documents using their own devices, reducing delays and supporting remote participation
Embedded within the Viedoc eClinical suite, enabling integration with other Viedoc modules

Benefits

Safety and security: Access controls and regulatory compliance protect the privacy of participants and site personnel
Flexibility: Supports decentralized and hybrid trial models by allowing participants to sign on personal devices
Transparency: Maintains detailed records to facilitate compliance verification during internal reviews and regulatory audits

Integration with the Viedoc eClinical Suite

Works alongside Viedoc EDC for electronic data capture and management
Integrates with Viedoc TMF for compliant document access and management
Connects with Viedoc Me for direct participant data collection
Compatible with Viedoc Share for secure exchange of study documents and files with personnel and participants

Viedoc eSignature is part of a broader eClinical platform and is suited for organizations requiring a compliant, device-flexible signature workflow that integrates with existing clinical data management and document sharing infrastructure.