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 GxP and 21 CFR Part 11 compliance. 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 ›

scientist using Watson LIMS software

Industries

 

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. 

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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.

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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.

Learn more 

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. 

Learn more 

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.

Learn more 

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.

Learn more 

 

Capabilities

 

manag-study
Manage study design and method validation

Emulate study protocols, perform method development and validation with complete reporting and documentation.

maintain-sample
Maintain sample chain of custody

Utilize the audit trail feature to monitor each movement a sample makes. Items such as sample storage location, shipment records, and freeze/thaw details are all maintained in the system.

direct-connection
Connect laboratory instruments and software

Reduce the risk of manual transcription errors by automating data capture and management processes.

Computer
Streamline sample analysis

Perform PK and ADA calculations and analyses with the software. Define run acceptance criteria and create flags for samples or QCs that are out of range.

Clipboard Checkmark
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.

check-marks
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.

 

Featured solutions

 

Pharmacokinetics-capabilities

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

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

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

Incurred sample reanalysis

Provides built in calculations and template options to report on incurred sample analysis results.

CDISC-datasets

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

Study design and sample management

Emulate a protocol design to create sample names and sample metadata to be used from planning through reporting. Identify 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.

 

 

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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.

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Chromeleon Chromatography Data System (CDS) software

Streamline your lab workflow with unified control, processing, and data management for your chromatography and mass spectrometry instruments.

Learn more ›

 

Resources

 

thermo-nerviano
Standardizing bioanalytical workflows at Nerviano Medical Sciences
thermo-creating-an
Creating an environment for bioanalytical excellence
thermo-veeda
Veeda Clinical Research Implements Thermo Scientific Watson LIMS to Automate Its Bioanalytical Research Facility
thermo-watson-lims-software
Thermo Scientific Watson LIMS software

Built for bioanalysis

Read more ›

thermo-watson-large-molecule
Watson LIMS software for large molecule bioanalysis

Power your bioanalytical workflows

Read more ›

solution to data heavy challenges facing genomics labs blog
How Can Thermo Scientific Watson LIMS Software Help to Address Recent FDA Observations?
The-Role-of-ADME-Toxicology-Studies-in-Drug-Discovery-Development-blog
The Role of ADME & Toxicology Studies in Drug Discovery & Development
business value of a lims blog
Business Value of a LIMS
Acceleration drug discovery in the digital age blog
Accelerating Drug Discovery in the Digital Age
strategy key to digital transformation blog
Strategy Key to Digital Transformation
machine learning a primer to laboratory applications blog
Machine Learning: A Primer to Laboratory Applications
thermo-nerviano
Standardizing bioanalytical workflows at Nerviano Medical Sciences
thermo-creating-an
Creating an environment for bioanalytical excellence
thermo-veeda
Veeda Clinical Research Implements Thermo Scientific Watson LIMS to Automate Its Bioanalytical Research Facility
thermo-watson-lims-software
Thermo Scientific Watson LIMS software

Built for bioanalysis

Read more ›

thermo-watson-large-molecule
Watson LIMS software for large molecule bioanalysis

Power your bioanalytical workflows

Read more ›

solution to data heavy challenges facing genomics labs blog
How Can Thermo Scientific Watson LIMS Software Help to Address Recent FDA Observations?
The-Role-of-ADME-Toxicology-Studies-in-Drug-Discovery-Development-blog
The Role of ADME & Toxicology Studies in Drug Discovery & Development
business value of a lims blog
Business Value of a LIMS
Acceleration drug discovery in the digital age blog
Accelerating Drug Discovery in the Digital Age
strategy key to digital transformation blog
Strategy Key to Digital Transformation
machine learning a primer to laboratory applications blog
Machine Learning: A Primer to Laboratory Applications

 

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