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Computer System OQ Template (RiskVal)

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

Provider: BPA
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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