LIMS

LIMS (Laboratory Information Management System)

LIMS is a computer application designed for the analytical laboratory to administer samples and  acquire data and report results via a database.

PRU use Watson-LIMS to ensure compliance with the strictest regulatory requirements support a wide range of workflows and reduce time to market.

LIMS contribution to both PRU and Sponsors

  • Will save time in preparing the sequences, injection and data handling at the analytical department  and minimize the paper work of checking, review  and approvals.
  • Using the Run acceptance template and sample re-analysis features, higher accuracy and faster judge on the data will be achieved.
  • Integrity of data will be guaranteed where the unknown concentrations will be directly exported to WinNonLin without using an editable documents (Such as excel).
  • Due to the large number of samples and the freezers at PRU, the sample entry features will ease the sample tracking for all samples from receiving until disposal.
  • Preparation for sample labels will be easier since they are automatically generated from the entered design.

Documentation for a LIMS Validation:

  • Validation Plan
  • Project Plan
  • User Requirements Specification (URS)
  • Vendor Audit Report
  • Purchase Order
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • PQ Plan
  • PQ Test Scripts
  • User Training, SOPs and System Documentation
  • Validation Summary Report