Process control in GMP laboratories
21 CFR Part 11–compliant control and tracking platform for a global life sciences client to control and log biofiltration device workflows, complete with audit trails, access controls, and e-records.
Overview
We designed and implemented a device-integrated software platform for a leading multinational in the life sciences sector. The platform enables secure, compliant operation of biofiltration devices used in biologics manufacturing and analytical testing.
Built to meet 21 CFR Part 11 compliance requirements, the platform includes role-based access control (RBAC), electronic signatures, audit trails, and version-controlled documentation workflows. It is deployed within the client’s customer environments and acts as the central interface for tracking device usage, executing testing protocols, logging results, and ensuring traceability in regulated labs.
Problem Statement
Our client needed a scalable, validated software solution to support their customers—regulated labs and GMP-compliant facilities—in managing device workflows. The key challenges included:
Manual tracking of device operations via spreadsheets and paper logs
Lack of traceability in protocol execution and sample handling
Compliance risks around access control, record integrity, and audit preparedness
Lack of a centralized interface for electronic documentation and QA review
To reduce compliance burden and improve customer experience, a purpose-built control platform was required.
Solution
We developed a compliance-focused control system that enables end users to execute and manage sample testing workflows linked to proprietary biofiltration hardware.
Key features include:
21 CFR Part 11–compliant design, with electronic signatures and validated audit trails
RBAC for our client's customers that enables role-specific access for operators, supervisors, and QA teams
Protocol management, including document upload, versioning, and approval workflows
Device-run tracking from protocol execution to result reporting
System-specific input validation, to ensure that new protocols remained within the hardware system's capabilities
Automated system alerts for pending actions or deviations
Electronic documentation that integrates with GMP batch records and audit processes
The system ensures secure, flexible, and audit-friendly workflows for customers while aligning with global regulatory requirements.
Our software development services included design traceability documentation, validation and verification, and version-controlled releases. We set up a complete bench-top test system in our facilities, where new releases and enhancements were validated before release.
How it works
Data security
The platform is installed on the customer’s devices and communicates directly with the manufacturer’s biofiltration devices. Users authenticate using role-specific credentials, and all system interactions are logged in a secure, timestamped audit trail.
Process control
Operators execute approved protocols, monitor real-time device status, and document run outcomes directly through the platform. Supervisors and QA personnel can access submitted reports, validate them through electronic signatures, and generate records for compliance or batch documentation.
Traceability
All activity is archived and searchable, supporting full traceability, audit readiness, and streamlined collaboration across regulated facilities.