Implementing Benchling Validated Cloud for a Biotherapeutic Company
Clarkston Consulting recently partnered with a biotech client on a LIMS solution. Read a synopsis of the project below or download the full Benchling Validated Cloud platform case study.
Download the Benchling Validated Cloud Platform Case Study Here
As an innovative biotherapeutic company that aims to treat a variety of diseases by modulating the human microbiome, this client has been growing rapidly and realized the need for a LIMS solution that would help manage the increasing amount of data. One of the biggest challenges this company faced was data integrity, as operational processes were executed using a combination of uncontrolled systems, excel spreadsheets, and paper forms. To achieve regulatory compliance and establish a clear data structure, the client embarked on a journey to implement LIMS internally.
The client had been implementing Benchling Validated Cloud to support their research & development (R&D), Quality Control (QC), Chemistry, Manufacturing, and Control (CMC), and Clinical Operations across multiple sites in preparation for a Pre-approval Inspection. However, the lack of implementation experience has led to significant delays in achieving project milestones. Deliverables weren’t clearly identified, and documentation was insufficient and disorganized. Additionally, cross-team collaboration efforts had been minimal due to the absence of proper project management.
The company quickly learned that a LIMS implementation is a complex and time-consuming process. They decided to engage Clarkston’s program management and LIMS experts to realign their ongoing LIMS implementation initiatives, develop a project plan, and define the scope with time and budget management.
The main objective for the LIMS implementation is to streamline data management that would help ensure data integrity in preparation for regulatory inspections. Clarkston designed and implemented a fully configurable LIMS following the Conceive, Design, Implement, Operate (CDIO) approach that transformed split processes into organized workflows and ensured traceability across functions while promoting collaboration with access-controlled data sharing. This resulted in a reduced risk of regulatory non-compliance and improved operational efficiency that will set a strong data foundation for future organizational growth.
Download the Benchling Validated Cloud Platform Case Study, and learn more about our LIMS Services by contacting us below.
Contributions from Cara Chiu and Rick Curtis
