LabWare Testing and Validation

LabWare's Approach to LIMS and ELN Validation

LabWare recommends a life-cycle validation approach for its customers based on the principles outlined in GAMP for Category 4, Commercial-off-the-shelf software (COTS) with configuration. LabWare has already qualified its LIMS and ELN, so a customer can follow a risk-based testing approach that focuses on the validation (or verification) of the configuration implemented to satisfy the customer’s user, business, and regulatory requirements.

LabWare validation services work with the customer to create a validation package that includes testing to verify the proper installation of the LabWare product(s), the proper operation of configured objects (based on the defined user and functional requirements), and that the system satisfies the business process for which it was implemented.

LabWare consultants work with the customer to identify the system’s business and regulatory risk and the complexity of configuration as defined by the functional requirements. The outcome of the risk and complexity assessments is then used to prioritize the validation efforts to ensure that high risk and complexity areas are properly mitigated through testing or by external processes such as work instructions or SOPs. The result is a high-quality system that has been properly tested and documented.

For Labware customers who are not bound by regulation to validate their system, LabWare recommends that the customer still invests in some level of testing or verification to identify and remediate any system issues that could impact business continuity after go live. The same risk-based principles apply to ensure both a right-sized testing effort and a high-quality system.

LabWare Validation Services Team is ready to provide the appropriate level of guidance, involvement, and service required to satisfy the customer's regulatory and non-regulatory expectations.