Comprehensive Guide to LabWare LIMS Testing and Validation Services

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Comprehensive Guide to LabWare LIMS Testing and Validation Services

Understanding Validation in Regulated Industries

LabWare Validation Services play a crucial role in steering customers away from nonessential activities and focusing on compliance activities that add real value to their Laboratory Information Management System (LIMS). Many customers in regulated industries face the challenging task of validating computer applications to meet stringent regulatory requirements. The FDA defines computer validation as the confirmation that software specifications align with user needs and intended uses, while verification ensures that design outputs comply with specified requirements at each phase of the software development life cycle.

LabWare's Validation Approach

LabWare recommends a life-cycle validation approach based on GAMP principles, specifically designed for COTS software with configuration. By offering a risk-based testing approach, LabWare focuses on validating the configuration to meet user, business, and regulatory needs. LabWare validation services include testing the proper installation and functioning of the LIMS, ensuring configured objects meet defined requirements, and confirming the system aligns with business processes. Consultants assess system risks and complexity, prioritizing validation efforts to mitigate high-risk areas and ensure a well-tested and documented system.

Range of Validation Services

LabWare's validation services cover various aspects, including defining process and user requirements, planning validation strategies, creating validation deliverables, executing test scripts, managing defect reports, conducting risk assessments, developing system-specific SOPs, and master data verification planning. These services assist customers in validating new implementations and maintaining existing systems in a validated state. The LabWare Validation Services Team offers guidance and support tailored to meet both regulatory and non-regulatory validation needs.

Benefits of Choosing LabWare for Validation

LabWare's validation professionals actively engage in software integration projects from the outset, viewing validation as a critical step to enhance project integration. With experienced professionals certified in LabWare LIMS configuration and software validation, LabWare ensures quality assurance throughout the implementation process. The internal Quality Systems and validation documentation support small-scale to global LIMS deployments. Customers with limited validation resources can rely on LabWare to manage validation efforts from strategy definition to execution, ensuring complete, compliant, and audit-ready LIMS system validation.

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Products-LabWare LIMS