Contents: Background | Introduction | Challenges | Journey | Why LabKey | Results | Conclusion
Background
The Gates Biomanufacturing Facility (GBF) at the University of Colorado Anschutz Medical Campus is a state-of-the-art contract development and manufacturing organization. It focuses on bridging the gap between scientific research and patient impact through the production of cell therapies and biologics in compliance with FDA’s current good manufacturing practices.
Introduction
GBF faced significant challenges with their previous freezer inventory software, which was prone to crashes and was losing support. They needed a robust, reliable solution that could integrate seamlessly with their operations, leading to the adoption of LabKey Sample Manager.
Challenges
The GBF started their search after encountering and identifying these challenges:
Unstable Software: Existing software was unstable and frequently crashed, causing data loss and operational delays. Additionally, upcoming discontinuation of support for the current system would leave GBF without critical updates or technical assistance.
Hosting Costs: High costs of hosting the old system on their own servers.
Resource-Intense Compliance: 21 CFR Part 11 compliance required significant operational time to maintain in the existing system, with inefficient tasks like routine manual backups and server restarts before system use.
System Flexibility: The need for a customizable system that could accommodate a variety of sample types and storage conditions.
User Interface: Demand for a user-friendly interface to minimize training time and maximize efficiency.
The Journey
The process of adopting LabKey Sample Manager involved several critical stages:
Identifying the Need and Forming a Team: The Gates Biomanufacturing Facility recognized the limitations of their existing freezer management software and formed a dedicated team to search for a more robust solution. This team was tasked with evaluating potential software replacements that could meet the complex needs of their facility.
Evaluating Software Options: After identifying several potential candidates, the team conducted extensive reviews and engaged in testing through free trials provided by the software vendors. This process was crucial in assessing the functionality and compatibility of each system with GBF’s operations.
Selecting LabKey Sample Manager: Following a comprehensive evaluation of various options, LabKey Sample Manager was chosen as the most suitable solution. The decision was based on its robust features, compliance with regulatory requirements, and the flexibility it offered for customization.
Planning for Data Migration and System Customization: With the software selected, detailed planning commenced for the migration of existing data into LabKey Sample Manager. This stage involved mapping out the data transfer process and customizing the software to fit the specific workflows and storage needs of GBF.
Implementation: The implementation phase included the actual migration of data, setting up the system configurations, and training staff on how to use the new software efficiently. This step was critical to ensure a smooth transition and to minimize any disruptions to ongoing operations at GBF.
Why LabKey
Sample Manager’s high customizability met GBF’s specific operational needs with it’s flexible sample management solution, including remote accessibility, reliable security, and intuitive design.
Ensures Compliance with Regulatory Standards: LabKey Sample Manager supports compliance with 21 CFR Part 11, which is crucial for maintaining data integrity and securing audit trails. This feature is essential for GBF, as it ensures that all digital documentation meets FDA standards, which is critical for audit readiness and regulatory compliance.
Customization for Specific Operational Needs: The software is highly customizable, allowing GBF to tailor it to fit their specific operational needs. This flexibility is vital for managing a variety of sample types and storage conditions, making it possible to adapt the system as the facility’s needs evolve over time.
Reliable Cloud-Based Infrastructure: LabKey runs on a robust cloud-based infrastructure provided by Amazon Web Services, which offers regular data backups and ensures high availability and security. This setup minimizes the risk of data loss and supports GBF’s requirements for high data security and reliability.
User-Friendly Interface: The interface of LabKey Sample Manager is designed to be user-friendly, significantly reducing the learning curve for new users and decreasing training requirements. This enhances operational efficiency by allowing staff to quickly become proficient in using the system.
Enhanced Accessibility and Remote Operations: The browser accessibility of LabKey Sample Manager enables GBF staff to access the system remotely, enhancing flexibility in operations and reducing dependency on specific workstations. This feature is particularly beneficial for enabling remote monitoring and management of sample data, which can be crucial for operations that span multiple locations or involve remote teams.
Results
LabKey’s support has been critical in optimizing Sample Manager for the lab and continuing to shape their use as the business evolves, resulting in:
Successful Data Migration and Integration: Following the implementation of LabKey Sample Manager, GBF successfully migrated over 13,000 rows of critical sample data within the tight timeline set for the project. This migration was seamless, with no data loss or corruption, demonstrating the robust capabilities of the new system.
Enhanced System Stability and Reliability: Since the transition to LabKey, GBF has reported zero interruptions or unexpected downtimes. The stability of the new system has significantly improved operational continuity, ensuring that clinical teams can process and send samples without delays.
Improved Operational Efficiency and Training: The adoption of LabKey Sample Manager has led to improved operational efficiency within GBF. The user-friendly interface has simplified the training process, allowing the facility to quickly bring staff up to speed. Within the first month of operation, GBF added 234 new samples to the system and trained 18 operators, showcasing the ease of use and efficiency of the software.
Ready for Audits with Enhanced Data Security: The system’s compliance with 21 CFR Part 11 has positioned GBF to be audit-ready at all times, with reliable audit trails, low maintenance, and secure data backups. This readiness enhances GBF’s confidence during both internal and external audits, securing their compliance with regulatory standards.
Conclusion
The adoption of LabKey Sample Manager has significantly bolstered GBF’s operational capabilities, enhancing both efficiency and compliance in their critical biomanufacturing processes.