Assessing LIMS Quality Control for a Pre-Commercial Biopharmaceutical Company
Clarkston Consulting recently partnered with a pre-commercial biopharmaceutical client on a quality control LIMS assessment. Read a synopsis of the project below or download the full case study.
Download the Quality Control LIMS Assessment Case Study Here
The client is a late-stage pre-commercial biopharmaceutical manufacturer who manufactures microbiologic products. The client has been implementing a Laboratory Information Management System (LIMS) for research and development (R&D) purposes but wanted to leverage the application for Quality Control (QC) use, if possible. The client engaged Clarkston to gather and document user requirements for a QC LIMS from QC subject matter experts (SMEs), evaluate the vendor’s ability to meet the requirements, and recommend a path to deploying a LIMS for QC use.
Clarkston led a series of workshops with SMEs covering Environmental Monitoring, Instrument Management, Laboratory Investigations, Lot Management, Method Execution, Sample Management, Standards and Reagents Management, Stability Management, and Reports and Trending, generating 240 user requirements.
The user requirements were reviewed by the vendor, who provided details on the requirements that could be met immediately and the timeline to meet the remaining requirements. Other details on customization and how the requirements were met were included in the response. Clarkston also had review sessions with the vendor representatives to discuss system architecture, configuration, and reporting. Clarkston performed an analysis of the vendor’s response and recommended to the client a vendor selection for an industry-standard LIMS followed by an implementation project.
