The method system suitability criteria for the analysis of acetaminophen are listed in Table 1. Here we illustrate the utility of MVM software in the validation of a method for the analysis of acetaminophen. To illustrate the straightforward operation and comprehensive functionality of MVM, the major steps involved in the workflow for a basic assay validation of the drug product acetaminophen are summarized in this work. In addition, Method Validation Manager allows you to be fully compliant with governmental regulations by providing data security, a full set of user privileges, audit trails, and automatic data documentation providing you with the necessary information and complete data traceability required for final reports and to pass audits and data reviews. When less software is required, the software that is business-essential can be deployed more quickly and efficiently. Software training and support is also minimized. Because MVM allows the entire chromatographic method validation process to be efficiently performed within Empower 2, fewer software applications need be deployed, validated, and maintained. MVM is business-critical software that can significantly reduce the time and costs required to perform chromatographic method validation. It provides easy data tracking and complete organization of validation data and results monitored by the built-in oversight of automated error checking. MVM is designed to streamline the setup, execution, calculation, and reporting of a method validation. Waters Empower 2 Method Validation Manager (MVM) Software, used in partnership with the ACQUITY UPLC System, can dramatically address these time-consuming elements of analytical method validation. The potential for errors in the many steps of the validation process is large and the time delays when errors occur can be costly. Some of the more time-consuming aspects of validation involve the creation of validation protocols and sample lists, tracking of the workflow from protocol to final reporting, the performance of calculations, and the intense need to organize and manage raw and processed data. It requires a large investment in personnel, materials, instruments, supervision, and, most of all, time. Method validation is a demanding activity. Method development, method validation, validation protocols, sample lists, compliance, data security This application note summarizes a more comprehensive piece on the efficiencies and productivities to be gained by use of Empowerâ„¢ 2 Method Validation Manager Software.
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