Developing and validating rapid assessment instruments Chatcamroulette
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 requirements specified in the URS can also form the basis for all of the validation testing requirements, test protocols and acceptance criteria.
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.