Thermo Scientific Watson LIMS is a proven, purpose-built Laboratory Information Management System specifically designed to support the complex workflows of bioanalytical testing for both small and large molecule candidates. It is widely recognized as the industry standard in bioanalytical support, relied upon by 18 of the top 20 global pharmaceutical organizations and many leading Contract Research Organizations (CROs).
Key Benefits & Capabilities:
Watson LIMS is a highly specialized, protocol-driven application that manages bioanalytical studies from initiation through study closeout. It is designed to reduce validation time and improve overall efficiency in Drug Metabolism and Pharmacokinetic (DMPK) studies. The system acts as a central hub for data and regulatory compliance, allowing multi-site and global operations to run off a single database.
Core features include flexible protocol-based study design, assay/method standardization, and integrated sample tracking with barcode support (including 2D barcodes) to maintain a complete chain of custody (tracking storage location, shipment records, and freeze/thaw cycles). It provides built-in functionality for Pharmacokinetic (PK) and Anti-Drug Antibody (ADA) calculations and analyses. The software automates data capture by interfacing with laboratory instruments, such as the TSQ Series mass spectrometers, to eliminate manual transcription errors.
For reporting and quality assurance, Watson LIMS includes over 150 pre-configured reports, ad-hoc reporting capabilities, and specialized Incurred Sample Reanalysis (ISR) reporting features. It also supports the assembly of datasets into CDISC SEND and SDTM formats to streamline regulatory submission processes.
Compliance and Security:
The software is developed with regulatory compliance as a core focus, enabling adherence to GLP, FDA 21 CFR Part 11, FDA Bioanalytical Method Validation, and EMA guidance documents. Security features include role-based access control, secure data transmissions, Encryption, and Single Sign-On (SSO), with comprehensive audit trails tracking all changes for enhanced traceability.