Pharmacokinetic (PK) and immunogenicity (ADA) calculations and analyses can be performed in the software, reducing the turnaround time for reporting on results. 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. The software provides a complete audit trail and establishes sample chain of custody. 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. 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. Implementing a laboratory information management system (LIMS) promotes visibility, quality, and integrity into the management of these items. ![]() 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. Bioanalytical testing plays a critical role in drug development they provide vital pharmacokinetic, pharmacodynamic, and immunogenicity data on a potential therapeutic.
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