Performance Qualification of Computerized Equipment

To describe the validation guideline for performance qualification of computerized equipment to ensure that it meets the performance 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 specific performance qualification protocol shall be prepared for each piece of equipment undergoing performance qualification. The performance qualification of the computerized system consists of accumulating enough evidence that the computerized system is in compliance with its intended specifications, when functioning for the concerned process at the production premises. 

The performance qualification of computerized control systems consists of a group of tests pooled in functional checks. The tests shall be carried out on the integrated system. The structure of the performance qualification shall be standardized for all performance qualification of computerized pharmaceutical equipment. 

Performance qualification documents shall include a paragraph stating the objective of the document and a paragraph specifying the scope of the document, i.e., the exhaustive list of the concerned equipment, or categories of equipment. 

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