Situation

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.

Objectives

The client's primary goal was to implement 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.

Challenges

1. Limited systems administrator resources: bench analysts were performing both data entry and administrative tasks
2. Limited laboratory informatics system expertise: project team members were well-versed in laboratory practices, but were not familiar with how to automate those tasks
3. Minimal experience with enterprise-level systems: many original paper-based systems were still in place, resulting in a culture that supported data silos
4. Need for business process engineering: standardizing processes for a global LIMS or ELN necessitates rigorous change management
5. Broad scope: any new system needed to accommodate both the R&D and QC laboratories, which had different processes and methods

CSols' 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

Benefits

• 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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