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Many of LabWare’s customers operate in regulated industries and face the challenging task of performing some level of validation and/or verification of their computer applications.
The FDA defines computer validation as “ Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Whereas verification is defined as “ ... providing objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase... ”.
While the FDA and other regulatory bodies define a validated (or verified) system, they provide little to no insight into actually validating (or verifying) a computer system.
LabWare helps companies define, plan, and execute a validation/testing strategy that gives the customer confidence that they have implemented a high-quality system that meets their business needs while also satisfying regulatory requirements.
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.
LabWare offers customers a wide range of validation services to assist LabWare customers with validating new implantations and/or maintaining previously implemented and validated systems in a validated state. These services include:
LabWare validation services can assist with other system validation activities and deliverables specific to customer validation procedures. Please contact your LabWare Account Manager to discuss your organization's specific validation needs.
LabWare views validation as a means to improve project integration from the outset, not as just a final step in the implementation process. LabWare's validation professionals take an active role from the beginning of the software integration project – as the system is being configured – and continues with quality assurance activities at each subsequent phase. Each LabWare validation professional is not only certified to configure LabWare LIMS but also has years of experience in software validation in both regulated and non-regulated industries.
LabWare's internal Quality Systems include comprehensive industry compliant project (SDLC) and validation documentation to support our software. LabWare's validation professionals are positioned to support the validation of a small single instance LIMS deployment or can develop and implement a tailored validation strategy for a global deployment model.
If a customer has limited experience or resources to carry out validation, the LabWare Services Team will manage all or part of the validation effort from strategy definition, SOPs, deliverables identification and creation, execution, and summarization Usage Certification. LabWare can provide the necessary resources to ensure that the LabWare LIMS/ELN integration is in a Qualified State. The LabWare Validation Services team will ensure that the customer LIMS system validation is complete, compliant, and the customer is confident, self-reliant, and audit-ready!
LabWare's years of experience, direct involvement with the product developers, and education in current validation trends makes the LabWare Validation Services team the best choice for validation resourcing needs.