Equilab Improves the Data Integrity of its Operations with NuGenesis Laboratory Management System

Significance of the Topic

Bioavailability (BA) and bioequivalence (BE) studies are essential in pharmaceutical development and regulatory approval processes. Ensuring accuracy, traceability, and compliance with international standards such as ISO 17025:2017 and Good Laboratory Practice (GLP) builds confidence among clients and regulatory bodies and supports global acceptance of analytical results.

Objectives and Study Overview

Equilab International aimed to upgrade its data management practices to achieve ISO 17025:2017 accreditation and GLP compliance. The primary goals were to enhance data integrity, streamline workflows, minimize manual transcription errors, and support audit readiness by managing electronic laboratory records and audit trails effectively.

Methodology and Instrumentation

Equilab selected Waters™ NuGenesis™ Laboratory Management System (LMS), which integrates a Scientific Data Management System (SDMS) and an Electronic Lab Notebook (ELN). Key elements of the implementation included:

• Conversion of existing Excel spreadsheets into ELN forms with built-in audit trails
• Centralized secure storage of analytical data and reports
• Role-based access control and electronic signatures to meet regulatory requirements
• Reduction of hard-copy printouts and manual handling of worksheets

Instrumentation deployed:

• Waters liquid chromatography–mass spectrometry (LC-MS) systems
• NuGenesis SDMS and ELN modules for electronic record management

Main Results and Discussion

Following implementation of NuGenesis LMS:

• Audit readiness improved through electronic traceability of all data manipulations. Each spreadsheet edit, version, and user action is logged in compliance with ALCOA data integrity principles.
• Turnaround time for QA data verification was reduced from 20 working days to 10 working days post-code release.
• Paper consumption per project decreased by over 50%, from an average of two reams to approximately 0.5–1 ream.

These enhancements supported more efficient bioanalytical processing of drug concentration samples in BA/BE studies and strengthened client and regulator confidence.

Benefits and Practical Applications

The integration of NuGenesis LMS delivered:

• Robust data integrity that aligns with ISO 17025:2017 and GLP standards
• Improved workflow efficiency by reducing repetitive data transcription tasks
• Enhanced document control and long-term data archival capabilities
• Global acceptance of test reports, facilitating international collaborations without repeat testing

Future Trends and Opportunities

Further developments may include advanced data analytics, machine-learning–driven method optimization, and expanded cloud-based collaboration. Broader adoption of integrated laboratory informatics will drive higher throughput, real-time monitoring, and predictive quality management in bioanalytical laboratories.

Conclusion

Equilab International’s deployment of Waters NuGenesis LMS successfully elevated its data integrity and operational efficiency. The solution enabled compliance with ISO 17025:2017 and GLP, reduced turnaround times, cut paper usage, and strengthened Equilab’s position as a trusted global bioanalytical provider.

References

1. ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories