IQ/OQ/PQ Requirements
Posted on Tue, Jan 17, 2012
Custom systems are treated in the same manner as commercial off-the-shelf (COTS) systems; that is, the proper installation of system components that meet technical requirements is verified, and the system is tested in a validation environment.
Computerized System Validation: Strategies for Achieving and Maintaining Part 11 Compliance in Today's Current Practices
The prepared test cases have to be executed at the appropriate times during a project. For example, test cases corresponding to smoke tests may be run on a daily basis. System testing test cases will be run during system testing. Test cases should be linked and traceable to user requirements and functional specifications in a traceability matrix.
Traceability matrix ensures that the requirements make it through the subsequent life cycle phases and do not get orphaned mid-course. In particular, the traceability matrix is a tool to validate that every requirement is tested. This is created during the requirements gathering phase itself by filling up the unique identifier for each requirement.
Subsequently, as the project proceeds through the design and coding phases, the unique identifier for design features and the program file name is entered in the traceability matrix. When a test case specification is complete, the row corresponding to the requirement which is being tested by the test case is updated with the test case specification identifier.
Test protocols should be used with information on the following subjects:
- Function that should be tested
- Steps to be performed
- Equipment used
- Data inputs and expected output
- Acceptance limit
- Name of test person
- Date of Testing
All traceability matrix implementation techniques need the commitment of a convicted team to manage the linkages between the requirements, their source, and their allocation to subsequent work products. Test planning involves both the definition of test requirements and the development of an approach for managing test requirements.
Test requirements management include the storage of requirements, maintenance of traceability links, test requirements risk assessments, sequencing (prioritization) and identification of test verification methods. Traceability links include the mapping of test procedures to test requirements and of defects to test procedures.
In the test plan, the team needs to outline the way in which the test requirements will be managed. Will test requirements be kept in a word-processing document, spreadsheets, or requirements management tool? Key considerations with regard to storage of test requirements include the ease of flexibility of requirement sorting and reporting, the ease and speed of requirement entry, and the efficiency of requirements maintenance.
Traceability between system requirements or use cases and various project products can become complicated very quickly.
The general GAMP states the need for IQ, OP and PQ requirements for equipment. The installation must be done according to the procedure and then tested – and the testing documented. This will assure that the system has been installed correctly and that it works correctly.
The OQ/PQ requirement tests must be verified against the requirement and documented. If equipment – for example, instruments – is to be connected to a system, the same procedure for IQ and OQ can be used throughout; these will include testing to ensure that the piece of equipment is communicating with the system.
