Tests Plans or Test Protocols are used to test System requirements previously established in specification documents. Test Plans refer to a more general testing strategy; Test Protocols are the actual testing documents.

Test Protocols are organized into collections of Test Cases which check a specific element of the system. Each test case is made up of a series of test steps. Each step should include an instruction, an expected result and the actual result. Any discrepancy between the expected result and the actual result should be tracked as a deviation. Deviations should be resolved before validation is complete.

Software validation usually uses three specific testing protocols:

• Installation Qualifications (IQ) verify that systems are on machines suited to run the software, that the system has been properly installed and that the configuration is correct. These requirements were outlined in the Design Specification.


• Operational Qualifications (OQ) verify that systems perform as expected. The OQ tests requirements outlined in the Functional Requirements.


• Performance Qualifications (PQ) verify that systems perform tasks in real-world conditions. The PQ tests requirements outlined in the User Requirement Specification.

Engineering Validations sometimes use two additional testing protocols:

• Factory Acceptance Test (FAT) - Factory acceptance tests are an attempt to verify that the equipment meets requirements outlined in the User Requirement Specification or Functional Requirements. FAT are performed at the point of assembly. Customers will often ask to be present for FAT, though the tests are usually performed by the manufacturer. Many companies do not allow the company to ship the item without passing the factory acceptance test, and some contractual payments are dependent upon the item passing FAT.


• User Acceptance Test (UAT) or Site Acceptance Test (SAT) - User and site acceptance tests verify that the item performs as required by the User Requirement Specification or Functional Requirements. Once an item passes UAT/SAT, it is ready for use, unless other contractual arrangements are made between the user and the vendor.

Testing Protocols should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.

Acronyms

Installation Qualification, Operational Qualification, Performance Qualification, Factory Acceptance Testing, User Acceptance Testing, Site Acceptance Testing, Factory Testing, User Testing, Site Testing, Acceptance Testing, FAT, SAT, UAT, IQ, OQ, PQ

Additional Resources

Validation Document Resources

• Validation Plans
• User Requirement Specification
• Functional Requirements
• Design Specification
• Testing Protocols
• Installation Qualification
• Operational Qualification.
• Performance Qualification
• Traceability Matrix
• Risk Assessment
• Testing Deviations
• Summary Report
• Change Control for Validated Systems

• Compliance Validation
• Computer System Validation
• Process, Design and Equipment Validation
• Cleaning Validation
• Frequently Asked Questions about Validation
• Training courses on writing Test Plans, Qualifications and Performing Computer Validation