Steps in validating an instrument

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The desired results are established in terms of specifications for outcome of the process.Qualification of systems and equipment is therefore a part of the process of validation.The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract Here, the software for a large radiotherapy device was poorly designed and tested.The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time.The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan.In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.

The Validation Master Plan is a document that describes how and when the validation program will be executed in a facility.Identifying these factors will help to minimize the misuse of antibiotics.► We evaluated a number of scales that were designed to measure the factors influencing the use of antibiotics. ► We evaluated the validation process, taking place in the development of each scale.Content validity, face validity, construct validity, and criterion-related validity were assessed in each scale.Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: It was proposed in direct response to several problems in the sterility of large volume parenteral market.

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