case-study

Case Study:  Leader in Commercial Laboratory Services Coordinates Workflows Across 20 Countries with Sapio ELN

Executive Summary

This leading commercial laboratory services organization, operating over 150 facilities in more than 20 countries, partnered with Sapio Sciences to equip its global scientific teams with the Sapio ELN. The Sapio ELN integrates seamlessly into digital workflows, supports a diverse spectrum of sample analysis platforms, complies with global GLP standards, and provides unsurpassed data privacy and security. 

This collaboration helps the organization sustain its leadership position by ensuring unwavering integrity, compliance, and security in digital laboratory operations, delivering the fastest and most reliable pathway for clients to bring compounds to market.

The Customer: Leading Commercial Laboratory Services Organization

Company Overview

This organization is a leader in commercial laboratory services, operating over 150 facilities in more than 20 countries. Its mission is to deliver the fastest and most reliable pathway for clients to bring compounds to market.

Background

When operating over 150 facilities in more than 20 countries, delivering the fastest and most reliable pathway for clients to bring compounds to market requires unwavering integrity, compliance, and security in digital laboratory operations. Regardless of location, scientists’ electronic laboratory notebooks must integrate seamlessly into digital workflows, support a diverse spectrum of sample analysis platforms, comply with global Good Laboratory Practice (GLP) standards, and provide unsurpassed data privacy and security. That’s why this leading commercial laboratory services organization partnered with Sapio Sciences to equip laboratory scientists worldwide with Sapio ELN and help connect and secure its global informatics network.

The Challenge: Unifying and Securing Global GLP Laboratory Workflows

Sustaining a leadership position in commercial laboratory services for decades necessitates continuous process improvement to consistently deliver the fastest, most reliable pathway for clients to bring compounds to market. This includes continually adapting and adhering to stringent, dynamic standards that ensure the quality and integrity of global lab operations. It requires modern informatics that connects thousands of scientists in labs worldwide in a secure, paperless operating environment that integrates digital data collection and reporting systems.

Commercial laboratories in different countries operate in accordance with GLP standards compliant with the U.S. Food and Drug Administration (FDA), the Organisation for Economic Co-operation and Development (OECD), and the European Medicines Agency (EMA), depending on the location and nature of the tests performed (i.e., discovery, preclinical, and clinical). Multiple laboratory analysis platforms include a wide range of instruments to meet clients’ diverse needs for analytical chemistry, immunology, genomics, LC/MS bioanalysis, LBA bioanalysis and biomarkers. Within this framework, the laboratory services organization aimed to integrate a cloud-based ELN into an established GLP-compliant system to digitize sample management and associated workflows.

The Solution: Sapio Sciences’ GLP-Compliant ELN

Why Sapio Sciences Was Chosen

The commercial laboratory services organization began evaluating ELNs based on GLP requirements for laboratory software, especially electronic records, electronic signatures, controls for closed systems, quality system regulation of automated processes, and secure cloud computing. Beyond just a vendor, it sought a partner that could provide an advanced ELN and a collaborative team to help meet its demanding customization, validation, and implementation challenges. It chose Sapio Sciences.

Implementation Overview

The unique requirements of a geographically dispersed, digitally unified GLP lab operation presented demanding validation and implementation challenges, including:

• Meeting demanding customization, validation, and implementation challenges for a geographically dispersed, digitally unified GLP lab operation, specifically:
• Requiring a highly configurable system with interconnectivity.
• Meeting regulatory requirements for all governing agencies.
• System operation across 9 time zones with different system outputs.
• Accommodating 17 sites, each with slightly different requirements and implementation timelines.
• Pre-loading the system with inventory items, storage locations, equipment, and other critical workflow information.

Hybrid Agile Methodology for Global Deployment

The teams employed a “hybrid agile” methodology adapted from software development for system design, agile implementation, integration testing, and deployment. Agile software development involves self-organizing, cross-functional teams to develop and deliver solutions to end users, in this case, 17 laboratory sites. Agile development requires adaptive planning, evolutionary development, early delivery, continual improvement, and flexible responses to change.

Overcoming Geographically Dispersed Challenges

This methodology enabled them to meet the demanding validation and implementation challenges of a geographically dispersed, digitally unified GLP lab operation by:

• Developing a minimum viable product (MVP) structure with checkpoints to ensure new features did not disrupt current functionality.
• Ensuring validation processes met regulatory requirements, including system operation across different time zones.
• Using feedback and focus groups to ensure all stakeholder voices were heard, with clear direction from global leadership regarding what was and wasn’t negotiable.
• Gradually migrating changes at each site’s required pace.

Key Features

• Sapio ELN: The core electronic laboratory notebook solution.
• Seamless Integration: Designed to integrate into existing digital workflows.
• Diverse Sample Analysis Platform Support: Capable of supporting a wide range of instruments for analytical chemistry, immunology, genomics, LC/MS bioanalysis, LBA bioanalysis and biomarkers.
• Global GLP Compliance: Adheres to standards from FDA, OECD, and EMA.
• Cloud-Based Operation: Provides a secure and accessible platform for global teams.
• Electronic Records & Signatures: Supports compliance with regulatory requirements for digital documentation.
• Controls for Closed Systems: Ensures data integrity and security within the ELN environment.
• Configurability & Interconnectivity: Allows for high customization and integration across diverse sites and systems.
• Validated Workflows: Includes validated workflows for LC/MS bioanalysis, analytical chemistry large molecule bioanalysis, and immunogenicity (for method development, sample dilution, and GLP sample analysis).

The Results: Enhanced Workflow Coordination and Compliance Across a Global Network

Through its partnership with Sapio Sciences, the commercial laboratory services organization can continue to improve its digital informatics network and help sustain its global leadership position.

Key outcomes of the Sapio ELN implementation include:

• Developing a minimum viable product (MVP) structure with checkpoints to ensure new features did not disrupt current functionality.
• Ensuring validation processes met regulatory requirements, including system operation across different time zones.
• Using feedback and focus groups to ensure all stakeholder voices were heard, with clear direction from global leadership regarding what was and wasn’t negotiable.
• Gradually migrating changes at each site’s required pace

Validating ELN Modules and Analytical Workflows

Within the flexible implementation framework, sample management, instrument maintenance, and inventory modules for the Sapio ELN were validated. In addition, LC/MS bioanalysis, analytical chemistry large molecule bioanalysis, and immunogenicity workflows were validated for method development, sample dilution, and GLP sample analysis. Cloud hosting was validated for data privacy and security.

Lessons for Commercial Laboratory Services Leaders

This organization’s journey offers critical insights for any commercial laboratory seeking to enhance its global operations and compliance:

• Prioritize Digital Transformation: Modern informatics is essential for connecting global scientific teams in a secure, paperless environment.
• Ensure Global Compliance: Solutions must adapt to and adhere to stringent, dynamic GLP standards across diverse international regulatory bodies (FDA, OECD, EMA).
• Seek Integrated Solutions: A highly configurable system with interconnectivity is crucial for complex, geographically dispersed operations.
• Adopt Agile Implementation: A “hybrid agile” methodology can effectively manage demanding validation and implementation challenges across multiple sites and time zones.
• Focus on Stakeholder Feedback: Using feedback and focus groups ensures all stakeholder voices are heard, facilitating smoother adoption and customization.
• Phased Migration: Gradually migrating changes at each site’s required pace is vital for successful global deployment.

Conclusion

The collaboration between this leading commercial laboratory services organization and Sapio Sciences demonstrates a successful blueprint for digitally unifying global GLP lab operations. By implementing the Sapio ELN and employing a “hybrid agile” methodology, the organization has enhanced workflow coordination, ensured stringent compliance across 20+ countries and 9 time zones, and solidified its position as a leader in delivering efficient and reliable pathways for clients to bring compounds to market.

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FAQ

Q: Why did this global CDMO/CRO select Sapio ELN?
A: To unify over 150 global lab facilities under a compliant, secure, cloud-based ELN that supports GLP operations across time zones.

Q: What was the key implementation approach?
A: A hybrid agile methodology that supported phased deployment, customization, and regulatory validation across 17 global sites.

Q: How does Sapio ELN enhance global compliance?
A: It supports FDA, OECD, and EMA regulations while securing digital workflows and data privacy across countries.

Q: What are the validated capabilities?
A: Sample management, LC/MS workflows, and inventory modules, all validated for GLP compliance.