Installation Qualification of Computerized Equipment

To describe validation guideline for the computerized equipment to meet the installation qualification 

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

Installation qualification shall include the verification that user manuals, technical manuals, and instrument calibration reports of the computerized system are available, complete, appropriate, relevant, and up to date. 

The installation qualification of automatic control systems shall consist of a logical panoply of tests. The tests are carried out step-by-step on each component. The structure of the installation qualihcation shall be standardized for all installation qualihcations of computerized pharmaceutical systems as follows. 

The documents description 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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