5.2.01 Evaluation program Estimated reading: 1 minute 38 views Authors Download the VA as PDF Download Aim and purpose Develop, implement and maintain an evaluation program (development process) to demonstrate the quality of services provided on an ongoing basis. The scope, organization, range, control and documented information are defined. Definition of development phases, risk assessment, evaluation procedures (validation, verification), responsibilities and authorities for development, management of departments involved in development. Determination and recording of development inputs, development evaluation, release Area of application Integration of new and existing processes into an established quality management system, Application of new procedures/methods in established clinical processes, e.g. the introduction of robotics in surgery and telemedicine, Redesign of clinical processes as a result of demand-driven performance, e.g. vaccination during pandemics, Redesign of processes due to unsatisfactory results, e.g. high rate of postoperative infections, Redesign of clinical processes as a result of serious adverse events, e.g. increase in drug-related side effects, Design of clinical trials (according to 7.3.1 note 2 of DIN EN 15224) Description Resources Risks Documentation Responsibility and qualification Notes and comments Applicable documents Literature Terms Attachments Annual development planDevelopment teamsConflicts of interest 5.2 Analysis and validation - Previous Clinical Trial Manual Next - 5.2 Analysis and validation 5.2.02 Design planning (development inputs)
