Ensuring Compliance: E-Signature with Immutable Audit Trail for Gene Therapy Workflow
The Challenge
The client, a leader in cell and gene therapy focused on cancer treatments, faced significant challenges in maintaining regulatory compliance and data integrity within their GxP-validated workflows. The key issues included:
- Inefficient Manual Signature Processes: The client’s traditional manual signature workflows were time-consuming, error-prone, and lacked real-time traceability for approvals.
- Lack of Auditability: Regulatory audits required clear visibility into approvals, including who authorized actions, when they were approved, and whether the actions were truly executed by authorized personnel.
- Compliance Risks: The absence of a secure, automated signature system raised concerns about maintaining full GxP compliance, risking potential audit non-compliance.
Our Solution
Agilisium’s solution was to implement a secure, automated e-signature system integrated with an audit trail to ensure compliance and streamline approval processes. This system was embedded within the client’s existing cell and gene therapy platform to meet regulatory requirements and optimize quality-driven workflows.
Key enhancements include:
SSO-Based Authentication
Ensures secure, streamlined access for authorized users, eliminating unauthorized access risks.
Immutable Audit Logs
Every signature and approval is stored in a secure, immutable log in AWS S3, ensuring traceability and accountability.
Metadata Tracking
Detailed tracking of signature data such as Email ID, IP Address, Timestamp, and Signature ID, ensuring full auditability of the approval process.
Notification Service
Alerts and notifications are sent to relevant stakeholders as approvals are completed, ensuring smooth communication and faster decision-making.
The Outcomes
The deployment of the e-signature solution empowered the client’s quality teams to manage approvals faster and with full traceability, improving compliance and reducing operational friction
40% Faster Approval Turnaround
The streamlined signature process reduced approval times, accelerating overall workflow efficiency.
30% Reduction in Manual Processing Time
Automated data capture and approval tracking eliminated manual documentation, significantly reducing processing time.
100% Audit-Ready Environment
The secure, traceable system ensures that all approval data is always accessible for audits, guaranteeing regulatory compliance.
Enhanced Data Integrity
Immutable logs ensure non-repudiation and full accountability, providing a secure audit trail for all approval actions.
Similar Case Studies
