Electronic signatures - once an unfamiliar or unused feature - have now become an essential capability within computerised systems supporting GxP operations across the regulated life-science industry. Today, solutions like Adobe Sign and DocuSign are widely used to route documents and records for review and approvals both within organisations and across external stakeholders. The rapid adoption of these eSignature systems as part of the overall drive towards digitalisation and automation in the industry means that it is essential to ensure that these systems have secure, traceable, and efficient workflows and functionalities that meet regulatory expectations.
Therefore, the real question is: Does the eSignature system, or the e-signature functionality embedded within a broader computerised system, comply with current regulatory requirements and can we demonstrate that compliance with appropriate evidence? GxP-regulated manufacturers, distributors or suppliers are responsible for ensuring that any computerised system they use to create, modify, maintain, review or approve GxP electronic records meets PIC/S Guide to GMP for Medicinal Products (PE 009) Annex 1 and/or FDA 21 CFR Part 11 requirements and other applicable data integrity elements.
The Computer Software Assurance (CSA) approach provides an efficient and effective pathway to validate GxP computerised systems by emphasising risk-based assurance activities, critical thinking and vendor collaboration to demonstrate regulatory compliance in system capabilities and thereby ensure product quality, patient safety and data integrity.
When applying CSA to eSignature systems, the first step is to understand the intended use of the system and the risks associated with any system failures. For example, an eSignature used to approve a critical (high-risk) batch-release records would warrant higher scrutiny than eSignatures applied to low-risk internal memos.
Once the intended use is aligned appropriately with the associated risk assessment, assurance efforts can be tailored appropriately. Instead of producing excessive validation test scripts, organisations can leverage the vendor's prior assurance evidence, perform focused functional verification tests, and rely on unscripted or exploratory testing wherever it adds value. For instance, a CSA approach for well-established SaaS platforms like Adobe Sign and DocuSign (often considered low-to-medium risk) allows organisations to produce efficient yet robust evidence demonstrating essential controls such as identity verification, audit trails, security measures, and record retention function as intended.
Ultimately, adopting the CSA mindset helps organisations ensure regulatory compliance, streamlines validation efforts, minimises unnecessary documentation, and accelerates deployment of modern, compliant eSignature solutions within GxP environments.
How MasterControl Strengthens eSignature Compliance
While standalone eSignature platforms help organisations route and approve documents, many life-science companies prefer a fully integrated environment where electronic signatures, audit trails, version control, workflows and secure record management all reside within a single validated platform.
SeerPharma is a strategic partner of MasterControl, which offers built-in, Part 11-compliant eSignature capabilities that are tightly integrated into:
- Document control and change management
- Training management
- CAPA and deviations
- Electronic batch records
- Supplier and risk management workflows
With MasterControl, organisations benefit from:
- native Part 11-compliant eSignatures with full traceability
- secure, audit-ready electronic records
- automated routing, escalations and approval workflows
- validation-ready platform aligned to CSA principles
- reduced effort in maintaining compliance across multiple external systems
- improved data integrity through a single source of truth
MasterControl’s cloud platform also provides vendor assurance documentation, validation packages, and continuous updates that support CSA-aligned lifecycle management. This reduces the validation burden for our clients and shortens our deployment timelines, all while maintaining GMP compliance.
Join our upcoming webinar on 10 December 2025 to understand how CSA transforms eSignature validation practices and how solutions like MasterControl help organisations stay compliant and audit-ready.
