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
If you would like to know more about this project or get help with your upcoming project, click here.
Check out more projects that CSols has worked on by clicking here.