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Computer System OQ Template (RiskVal)
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
Price:
$99.00
Product Details
- 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
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