A pharmaceutical manufacturer was growing rapidly and struggling to maintain compliance with its paper-based laboratory processes. The client selected CSols Inc. to perform a market evaluation and assist with identifying and purchasing a laboratory informatics system to address compliance needs, improve laboratory efficiency, and support continued growth.
The client’s primary goal was implementing a system to increase regulatory compliance, improve data integrity, and streamline processes in its QC and R&D laboratory organizations. Any new system must meet enterprise-wide IT and scientific needs.
- Limited systems administrator resources: bench analysts were performing both data entry and administrative tasks
- Limited laboratory informatics system expertise: project team members were well-versed in laboratory practices, but were not familiar with how to automate those tasks
- Minimal experience with enterprise-level systems: many original paper-based systems were still in place, resulting in a culture that supported data silos
- Need for business process engineering: standardizing processes for a global LIMS or ELN necessitates rigorous change management
- Broad scope: any new system needed to accommodate both the R&D and QC laboratories, which had different processes and methods
CSols’s Role in the Solution
- Supported evaluation and selection of SampleManager LIMS™
- Developed implementation strategy and LIMS roadmap
- Managed the global project team members and directly supported the steering committee for the project
- Developed a plan to create a new group, the Global Quality and R&D Laboratory Systems group, which supported the LIMS implementation, compliance and data integrity goals and is responsible for the on-going maintenance and growth of the system
- Acted as the director of the new Global Quality and R&D Laboratory Systems group and managed the recruitment and hiring processes for new staff members
- Developed a full range of validation documentation, including a validation plan, a risk assessment plan, validation protocols, and test scripts
- Improved regulatory compliance by supporting a constant state of audit readiness
- Reduced laboratory downtime and business interruptions via the Global Quality and R&D Laboratory Systems group, who could now address issues quickly
- Maximized equipment and resource utilization via electronic resource management in LIMS
- Increased laboratory efficiency and effectiveness with globally standardized, automated LIMS processes
- Reduced paper-based processes, improved data capture, and decreased turnaround times
- Increased information sharing, which accelerated the process of making manufacturing and business decisions
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