Sample computer system thesis

Table of Contents:

1. Computerized System Validation (CSV) Master Plan
2. CSV SOPs integrity
3. User Requirement Specifications (URS)
4. System Risk Assessment
5. Vendor Assessment
6. Validation Protocol in general
7. Test Plans in general
. Test plan approval
. References to specifications
. Instructions
. Judgeable
. IQ test plans and reports
. OQ test plans and reports
. PQ test plans and reports
8. Validation report
9. SOPs and Procedures
. System management
. Configuration management
. Security Management Procedure
. Back-up procedures
. Change control
. Maintenance und problem
. Operating Instructions
. Training
10. Response Approval

  • 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.
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Sample computer system thesis

sample computer system thesis

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