Laboratory software built for bioanalysis
Laboratory software built for bioanalysis play a critical role in preclinical and clinical studies, and ultimately to the approval of a new drug. Bioanalytical laboratories need to have complete management and oversight over items such as sample management processes, study protocols, assay development and validation, analytical runs, and the flow of data. Implementing a laboratory information management system (LIMS) promotes visibility and integrity in sample management, study protocols, assay development and validation, analytical runs and the flow of data. 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.
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Complete study and sample lifecycle management
Watson LIMS software follows your bioanalytical study from initiation through study closeout. 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 design and implement method development and validation assays for accuracy, precision, selectivity, sensitivity, reproducibility, and stability in Watson LIMS 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 can be established in the system.
Ensuring the integrity of your sample is one of the highest priorities during a bioanalytical study. Each sample is easily identified with a unique barcode, making compliance checks and audits much easier. Watson LIMS software provides a complete audit trail for the movement of each sample. Items such as sample storage location, shipment records, and freeze/thaw details are all maintained in the software.
Enable audit readiness and compliance
Watson LIMS software was designed to enable compliance with 21CFR58, FDA and EMA Bioanalytical Method Validation guidance documents, 21CFR11, and the CDISC SEND Implementation Guide. Electronic signatures are captured in the system and record items such as the user identity, time/date stamp, and reason for save. Watson LIMS software enables audit readiness, audit trail records are stored in the database and are readily retrievable for review.
Chad Briscoe of PRA Health Sciences discusses why they chose Watson LIMS software to overcome data challenges in regulated bioanalysis.