Traceability information system Watson LIMS™

for sample trackingclinical trial managementdata management

Overview
Manage bioanalysis studies from project initiation through study close with the Thermo Scientific™ Watson LIMS™. Designed for bioanalytical workflows for small and large molecules, Watson LIMS™ supports data handling, auditability and regulatory requirements typical of clinical bioanalysis and CRO-laboratory collaborations.

Main benefits

• Handle bioanalytical workflows for small and large molecules within a single LIMS
• Harmonize laboratory processes across multiple sites
• Facilitate information exchange between sponsors and contract laboratories
• Improve productivity by automating data management and report generation tasks
• Support compliance with standards such as 21 CFR Part 58 throughout the workflow
• Implement quantitative concentration assays and qualitative immunogenicity (ADA) assays
• Track sample history from receipt to disposal
• Enforce SOPs and reduce risk of non-compliance

Features and technical capabilities
Solution engineered for bioanalysis: supports PK and immunogenicity (ADA) studies with study configuration, sample tracking, raw result integration, QC and results review tools. Capable of importing raw results, performing standard regression analyses and immune-response analyses, applying Run Acceptance Templates and a two-operator review process.

• Aliquot management (splits): multiple aliquots per sample, manual or via spreadsheet import
• Interoperability: instrument integration via Integration Manager; supports secure interfaces (e.g. SOFT-interface) for selected vendors
• Data export: supported formats include Excel, CSV, Rich Text Format, PDF and single-page web export
• Integrity control: system does not generate automatic checksums for exports; digital signature options available via certain interfaces
• Authentication: LDAP and Single Sign-On (SSO) support
• Workflow support: create/validate batches (Calibration, QC, Test Batches) with or without spikes; automated or assisted sample selection for ISR based on configurable rules

Technical characteristics / specifications

• Brand: Thermo Scientific™
• Commercial name: Watson LIMS™
• Catalog reference: INF-21000
• Type: Watson LIMS software
• Unit size: Each
• Regulatory support: supports compliance with 21 CFR Part 58 requirements for bioanalysis
• Supported export formats: Excel, CSV, RTF, PDF, single-page web
• Authentication: LDAP / SSO
• Aliquot management: yes (splits)
• Available documents: brochures, case studies and technical references in PDF