Multiple Environments Bring More Control to Your Lab’s Software Systems

Significance of the Topic

The paper addresses the necessity of adopting multiple software environments in regulated laboratory settings to maintain data integrity, ensure compliance with GxP standards, and reduce risk associated with system updates, custom developments, and disaster recovery. By segregating development, testing, and production stages, laboratories can reliably manage software patches, application upgrades, and configuration changes while protecting critical production data.

Study Objectives and Overview

This white paper examines common challenges in operating a single production environment throughout a system lifecycle. It proposes a multi-environment architecture—consisting of Development, Test, and Production setups—and evaluates how this model mitigates risks from:

• Operating system and infrastructure updates
• Application and instrument driver upgrades
• Trial restores and backup verification
• Customizations and high-risk developments

Methodology and Instrumentation

The authors analyze regulatory guidelines PIC/S Annex 11, ISPE GAMP 5, and EU Directives alongside real-world use cases in QC labs. They detail typical software landscape components and map each to potential risk scenarios. Key systems and modules discussed include:

• Empower Chromatography Data System (CDS) and modules MVM, SSG, BC LAC/E
• NuGenesis Scientific Data Management System (SDMS)
• NuGenesis Lab Management System (LMS)
• waters_connect System Monitoring
• Services Toolkit Applications

Key Results and Discussion

Adopting separate environments delivers the following advantages:

• Development Environment: Safe sandbox for patches, feature testing, and custom developments without affecting GxP data.
• Test Environment: Controlled validation of updates, forms, and instrument connections, ensuring readiness before promotion.
• Production Environment: Protected repository for GxP data with minimal downtime, supported by pre-validated updates.

The paper presents risk–outcome tables that illustrate how multi-environment strategies eliminate disruption to routine operations, reduce data loss, and streamline regulatory compliance.

Benefits and Practical Applications

A multi-environment approach helps labs to:

• Implement OS patches and software upgrades without halting production testing.
• Verify backup and restore processes safely in non-production systems.
• Isolate custom developments to maintain audit trail integrity in production.
• Align with regulatory expectations for timely system updates and robust validation.

Future Trends and Opportunities

Emerging trends include leveraging virtualization and cloud platforms to rapidly provision and refresh separate environments at lower cost. Integration of automated monitoring, risk-based change management, and continuous delivery pipelines can further optimize validation efforts. Advanced analytics and AI may support proactive detection of vulnerabilities and streamline decision-making around environment promotions.

Conclusion

Multiple, purpose-driven environments offer a pragmatic solution to balance system currency and regulatory compliance in GxP laboratories. By segregating development, validation, and production tasks, organizations can reduce risk, protect data integrity, and ensure uninterrupted laboratory operations.

References

1. G. Orwell, Animal Farm, London: Secker and Warburg, 1945.
2. PIC/S, PI 011-3 Good Practices for Computerised Systems in Regulated GxP Environments, 2007.
3. ISPE, GAMP 5 Second Edition: A Risk-Based Approach to Compliant GxP Computerized Systems, 2022.
4. Center for Strategic & International Studies, 2021. Cyberattack data.
5. European Commission, Directive 2001/83/EC on Community code for medicinal products, 2001.
6. PIC/S, PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, 2021.
7. EudraLex Annex 11 Computerized Systems, 2011.