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GUIDANCE - ITEMS TO EVALUATE IN AN IQ, OQ, AND PQ FOR A COMPUTER SYSTEM
One of the difficult questions, especially for the first several validations, is what do I need to test in each of my IQ, OQ, and PQ protocols. This document explains 15 types of items that may need to be tested in one or more of the protocols for a system. In addition, it explains 11 types of testing that can be used for each dimension. While using test data is the most common type of testing, one of the other options may be better suited to your system or the context in which it is used. 13 pages
Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Shipping: Available for download - Link will be provided in My ComplianceOnline section
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- The purpose of this procedure is to provide guidance on what to test in IQ, OQ, and PQ protocols for computer systems.
- The tests in the IQ of hardware and system software should correspond to the requirements defined in technical requirements for the system, or the specifications identified in the system specification. Also see TEMP004 for instructions and examples for how to write the IQ.
- The functionality tested in the OQ should correspond to the functionality defined in the functional specification (or user requirements including supportive operations) for the system.
It Provides information on:
- Responsibilities
- Method
- Quality records
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