Deployment and Validation of an R&D LIMS for a for a major Pharmaceutical Company
CSols staff performed multiple roles over a two- year period assisting the pharmaceutical company with the selection, implementation and validation of an R&D LIMS. Critical roles/tasks performed by several members of CSols staff included:
- LIMS Strategic Planning
- Selection Process resulting in the Selection of LabWare LIMS 5.02
- LIMS Project Management and Methodology
- LabWare Configuration
- Development of the Validation Plan
- Development of the User Requirements Specification
- Review of the Configuration Specification
- Development of PQ Scripts
- Liaison between the pharmaceutical company and the LIMS Vendor
The client’s objectives included the following:
- Implement a LIMS solution for R&D and also
- The solution must be 21CFR Part 11 compliant. The validation will be based on the GAMP 4 model;
- The LIMS system must include interfaces to Empower
In order to achieve these objectives the clients faced the following challenges:
- Lack of business and technical resources to manage and execute the validation process;
- Aggressive timelines;
- Much of the infrastructure for the system would be located, remotely, in the United Kingdom, and various sites throughout Europe.
The CSols team managed the project, starting with the initial project organizational meetings with the stakeholders, and continued throughout the gathering of User Requirements, creation of the Validation Plan and its execution.