Operational Qualification of Computerized Equipment

To provide the guideline for the operational qualihcation of computerized equipment to ensure that it meets the equipment operational requirement 

It is the responsibility of the production manager, technical service manager, and computer manager to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

A specihc operational qualification protocol shall be prepared for each piece of equipment undergoing operational qualification. 

The operational qualification of computerized systems consists of a group of tests, pooled in functional checks. The tests are carried out step by step on each component. The general approach used is of the gray-box type. More precisely, study the input and output data transmission at intermediate points. The structure of the operational qualihcation may be standardized for all operational qualihcation of computerized pharmaceutical equipment. 

The objective of the document and the scope of the document, i.e., the exhaustive list of the concerned equipment or categories of equipment, are the operational qualihcation documents to be included. 

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