Watson LIMS Software 

Thermo Scientific Watson LIMS Software creates efficiencies and promotes compliance for bioanalytical labs, whether you work with small or large molecules. 

Watson LIMS Software has been trusted by the pharma industry since 2001. The software enables complete traceability and control throughout your bioanalytical study, from initiation through study closeout, while enabling compliance with regulations including GLP, 21 CFR Part 11, and FDA Bioanalytical Method Validation and EMA guidance documents. 
 

In the last five years, Waston LIMS Software users have had over 4,500 drugs approved for use across North America and Europe. With Watson LIMS Software, you can summarize assay performance results and study sample results, including the assembly of datasets into SEND and SDTM formats. In addition, Watson LIMS Software lets you emulate study and amendment protocols, providing assurance that what occurs in the system is in exact alignment with the study protocol. 

 


Watson LIMS Software capabilities

Manage and build study designs

Upload sample manifests using templates with the aid of Import Study Protocol to reduce metadata transfer errors.

Maintain sample chain of custody

Record all sample shipments and monitor each sample movement, define storage locations down to plate position, and track freeze/thaw cycle and sample stability. Easily provide chain of custody records to auditors. 

Connect lab instruments and software

Reduce the risk of manual transcription errors by automating data capture and management processes. Watson LIMS Software integrates easily with instrumentation through established interfaces (e.g., Sciex Analyst software). 

Streamline method validation and sample analysis

Conduct concentration evaluations for pharmacokinetics (PK)/ anti-drug antibodies (ADA) assessments, establish acceptance standards, and highlight results exceeding the range. Mitigate the risk of over- or under-reporting final concentration data through Internal Standard Review.

Execute efficient reporting and QA review

Generate a full study report including method validation experiments, assay performance, and study data. Report your data in CDISC, SEND and SDTM formats to help streamline submissions. 


Ensure traceability throughout a study

Get complete study records and reports from study initiation through study closeout, including sample chain of custody, assay verification, and reconstruction events using the audit trail.  

 

Get built-in security and audit trail

Benefit from maximum flexibility and configurability while preserving data integrity. System and study access are granted to authorized role-based users only, in accordance with Good Laboratory Practices (GLP). 

Simplify compliance 

Create labels according to study requirements, and display and barcode storage facilities to ease identification and traceability, enabling audit compliance with 21 CFR Part 11, FDA Bioanalytical Method Validation, and EMA guidance. 

Streamline data processing and reporting

Easily generate a variety of graphs, tables, and statistical calculations from study data. Easily sort, find, filter, and reorder grid contents, for a quick way to review a specific sample’s data. 

Minimize quality review time

Get real-time snapshots of data quality and easily transfer study data between sponsor and CRO due to pre-defined assay performance and summary tables.