Validation Protocols

Home > Services > Validation > Validation Protocols

LabWare supplies detailed validation protocols for performing an Installation Qualification (IQ), an Operational Qualification (OQ), and a Performance Qualification template (PQ). LabWare IQ Protocol - the purpose of the LabWare IQ Protocol is to provide a detailed test plan with test scripts that enables a customer to validate and document that LabWare LIMS is properly installed on a particular hardware configuration, network, operating system, and ODBC driver. In addition to the test plan and scripts, LabWare provides an automated validation tool that can document and test the LIMS to database connection. This tool sends typical and non-typical data from LIMS to the database, and then reads them back, doing a detailed binary comparison to ensure that the communication works as expected. This process can easily be run on all Client PCs. LabWare OQ Protocol - the purpose of the LabWare OQ Protocol is to test that the LabWare LIMS functions perform as they were intended to on a particular combination of hardware, operating system software, network, and ODBC driver. To accomplish the OQ, LabWare provides a pre-configured LIMS database that contains all of the necessary sample login templates, analysis methods, and pre-built Crystal Reports and Microsoft Office reports. This material is identical to the internal testing material used within LabWare. LabWare PQ Template - the purpose of the LabWare PQ Validation Template is to specify the required activities, testing, and validation documents that need to be created to validate the system to GAMP Category 4 guidelines (Configurable Software Package). The PQ is a comprehensive process that is designed to assure that the LIMS will operate and perform as expected on the production system. The PQ utilizes scenarios to affirm that the LIMS operates correctly in the context of the User Requirements Specification (URS). The templates cover areas of the software that are usually configured as part of an implementation.