Computer System OQ Template (RiskVal)

• 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.

It Provides information on:

• System description
• Responsibilities
• Validation approach
• Sampling plan
• Acceptance criteria
• Protocol report