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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Product Detail:
This protocol provides documented evidence that the [system name] performs as described in the User Requirements specification. This protocol tests/verifies [specify]. This protocol is compliant with the requirements of VAL004.
Validation is responsible for protocol generation and for assuring that the user requirements are appropriately tested.
Quality Assurance is responsible for the review and approval of the OQ protocol as it relates to current good manufacturing practices (cGMPs) ,and other regulatory requirements.
Provide data needed to set up the users in advance of executing the protocol so that they have the appropriate privileges.
Protocol test sections can be created for testing different aspects of the system.
