Phone (302) 731-5290

CSols, Inc.

Implementation and Validation of a LIMS system for a QC laboratory

Client Objectives:

  • Implement the LIMS system on a fast track (nine months) to be ready for an anticipated FDA pre-approval inspection.
  • Alter the sample life-cycle to better account for the chain of custody required by Client.
  • Implement a custom Invalid Results module for tracking and monitoring OOS (out of specification) results.

Client Challenges & Problems:

  • Implement the system in approximately ½ the industry average time span for a validated LIMS implementation project.
  • Customize the system to accommodate Client processes for sample chain of custody and OOS results monitoring.
  • Create a set of SOPs governing the use of the LIMS in the QC laboratory.
  • Create a view to the external SAP database for look-up of the Client Batch numbers.
  • Populate the LIMS test and specification tables from the existing diverse set of data dictionaries maintained by the Micro, BioAssay, BioAnalytical, Raw Material and Stability laboratories.

CSols Role & Expertise:

  • The two CSols associates assigned to the project brought 23 years of Computer Systems Validation experience and 22 years of experience programming and system management experience on LIMS systems.
  • CSols role was twofold:
    1. Validation Consultants: Starting with the User Requirements document, create the remaining set of validation deliverables as per the SDLC methodology.
    2. Subject Matter Experts: Act as subject matter experts in identifying configuration issues and recommending corrective actions while drafting the OQ and PQ test scripts.

How was CSols able to help?

Because of CSols experience with LIMS systems, CSols was able to quickly identify configuration issues during the OQ script development phase of the project, and relay the issues in system specific terminology to the LIMS development team. This was particularly valuable since, due to the project’s time constraint; there was no formal user acceptance test phase of the project.

How did we go about performing our work to help solve their problem and meet their needs?

  • At Clients’ request, CSols maintained on-site presence 75 – 80% of the time for the duration of the project. CSols tactic was to rotate consultants, thus minimizing the amount of travel required of each individual consultant.
  • Off-site, CSols was given remote access to the Client systems. This allowed CSols consultants to work productively toward project goals while not on-site.