Developing and validating rapid assessment instruments Sex video chat fanny
This activity can be completed prior to purchasing the RMM system or can be incorporated into the formal VMP.The URS should include requirements that the RMM supplier should meet.A risk assessment should be performed prior to the start of any RMM validation activities.Identified risks will vary depending on the RMM technology and the RMM supplier, the method the RMM is intended to replace, the product or sample(s) for evaluation, whether the new measurements are qualitative or quantitative and if the resulting data are significantly different from the existing method, method variability, method robustness, pharmacopeial equivalence, regulatory acceptance, and other attributes.Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.The following sections provide an overview of how to design a meaningful validation program in order to effectively demonstrate that the new RMM is equivalent to, or better than, the existing method you intend to replace.The data obtained from these initial studies will help with the decision to purchase the RMM and proceed with formal validation activities.The due diligence process also involves a review of existing regulatory commitments and whether implementing the RMM will result in significant changes that will require a formal submission.
From here, the user can develop specific requirements for the entire RMM system, including the equipment and the analytical method, which will demonstrate that the system performs as expected.
Therefore, careful planning and fact finding during the due diligence phase is critical to a successful RMM validation and implementation program.
In order to design a holistic approach to RMM validation, it is necessary to develop a comprehensive strategy that includes qualifying not only the RMM instrumentation but the analytical method as well.
The document that describes the functions and characteristics that the RMM system must be capable of performing is called the URS.
The requirements specified in the URS can also form the basis for all of the validation testing requirements, test protocols and acceptance criteria.