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This IQ template provides extensive instructions on how to create an installation qualification protocol for a computer system. It includes examples of items to verify for 15 different types of hardware and software.
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This OQ template provides extensive examples and instructions on how to create an Operational Qualification (OQ) for a computer system. The general format for the OQ protocol is also applicable for OQs for other types of items, such as equipment, facilities and utilities. 27 pages
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This PQ template provides extensive examples and instructions on how to create a Performance Qualification protocol for the validation of a specific computer system.
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Computers are widely used during development and manufacturing of drugs and medical devices. Correct functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data.
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