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Watson LIMS software enabling efficient and high-quality bioanalytical testing
Bioanalytical testing plays a critical role in drug development; they provide vital pharmacokinetic, pharmacodynamic, and immunogenicity data on a potential therapeutic. Bioanalytical laboratories need to have complete management and oversight over items such as sample management, study protocols, assay development and validation, analytical runs, and the flow of data. Implementing a laboratory information management system (LIMS) promotes visibility, quality, and integrity into the management of these items. Thermo Scientific Watson LIMS software was designed specifically with a focus on creating efficiencies and promoting compliance for bioanalytical laboratories, whether you are working with small or large molecule candidates.
Watson LIMS software follows your bioanalytical study from initiation through study closeout, all while enabling compliance with regulations including GLP, 21 CFR Part 11, as well as FDA Bioanalytical Method Validation and EMA guidance documents. The software provides a complete audit trail and establishes sample chain of custody. Study and amendment protocols can be emulated in the system providing assurance that what occurs in the system is in exact alignment with the study protocol. Lab managers can implement and report on method validation parameters, such as precision and accuracy, matrix effect, recovery, selectivity, and stability within the software. Pharmacokinetic (PK) and immunogenicity (ADA) calculations and analyses can be performed in the software, reducing the turnaround time for reporting on results. Run acceptance criteria, flags for out-of-range results, reassay, and incurred sample reanalysis procedures are all capable of being established within the system. Watson LIMS software enables summarizing assay performance results and study sample results, including the assembly of datasets into SEND and SDTM format.
Explore additional LIMS options from Thermo Fisher Scientific ›
Bioanalysis in Pharma
Watson LIMS software was designed specifically for bioanalytical testing. The software is used by the top pharmaceutical and contract research organizations (CROs) in the industry.
Contract Laboratories
Sponsor organizations rely on contract research, testing, and manufacturing facilities to produce results of high integrity and quality. Watson LIMS software enables this process.
Vaccine R&D
Selecting the right informatics capabilities can be key to driving your R&D pipeline, shortening research cycles, and boosting your program’s efficiency. Implementing our LIMS software for vaccine development can help improve speed to market, quality, and operational productivity/efficiency.
Bioanalysis in Pharma
Watson LIMS software was designed specifically for bioanalytical testing. The software is used by the top pharmaceutical and contract research organizations (CROs) in the industry.
Contract Laboratories
Sponsor organizations rely on contract research, testing, and manufacturing facilities to produce results of high integrity and quality. Watson LIMS software enables this process.
Vaccine R&D
Selecting the right informatics capabilities can be key to driving your R&D pipeline, shortening research cycles, and boosting your program’s efficiency. Implementing our LIMS software for vaccine development can help improve speed to market, quality, and operational productivity/efficiency.
Manage study design
Build study designs with the aid of Import Study Protocol to upload sample manifests using templates to decrease metadata transfer errors.
Maintain sample chain of custody
Utilize the storage report feature to monitor each sample movement. Items such as sample storage location, shipment records, and freeze/thaw records are all maintained in the system.
Connect laboratory instruments and software
Reduce the risk of manual transcription errors by automating data capture and management processes.
Streamline method validation and sample analysis
Perform concentration measurements for PK as well as ADA analyses. Define run acceptance criteria and flag results that are out of range. Reduce the risk of over- or under-reporting final concentration data with dedicated Internal Standard Review workflow.
Execute efficient reporting and QA review
Generate a full study report including method validation experiments, assay performance and study data within the system. Data can be reported in CDISC SEND and SDTM format to help streamline the submission process.
Ensure traceability throughout a study
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.
Pharmacokinetics capabilities
Performs non-compartmental pharmacokinetic and toxicokinetic calculations and analyses from back-calculated concentrations generated in LIMS to support in vivo study PK and drug exposure endpoints.
Immune response module
Enables the tiered approach for screening, confirmatory, titer, and neutralizing immunogenicity assays to support in vivo study immune response endpoints.
Run acceptance template and reassay decision matrix
Assesses run performance against pre-defined criteria and creates system flags for out-of-specification results. A graphical workflow of reassay decisions can be configured to automate decisions and adhere to defined procedures.
Incurred sample reanalysis
Provides built-in calculations and template options to report on incurred sample analysis results.
CDISC datasets
Export non-clinical and clinical datasets in accordance with implementation guides for PP, PC, LB, and IS domains.
Study design and sample management
Build or import a protocol design to create sample names and sample metadata to be used from planning through reporting. Identify the current location of samples and reconstruct sample chain of custody.
Deployment options
Streamline your implementation process with Watson LIMS software. The system utilizes established processes and templates requiring minimal configuration to meet your bioanalytical laboratory’s specific needs. Our team of experts not only understands the complex requirements of a bioanalytical lab, they also have the experience required to ensure every Watson LIMS software implementation is a success. Smaller CROs need not worry about the initial IT hardware costs and ongoing support requirements of adopting the industry-standard LIMS for bioanalytical study management. Customers can deploy Watson LIMS software in the cloud to enable secure and scalable end-to-end study and data management.
Informatics software
Your informatics system can be expanded and enhanced by connecting with other software products. Our full suite of lab informatics capabilities delivers the right solution to fit your unique needs.
Data integration software
Our complete suite of integration tools include integration, data visualization, e-commerce, services, and software to help you uncover the hidden value of your data.
Chromeleon Chromatography Data System (CDS) software
Streamline your lab workflow with unified control, processing, and data management for your chromatography and mass spectrometry instruments.
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