Considerations When Validating Your Analyst Software
What is Validation? Validation is to give confirmation by examination and provision of objective evidence that software specifications adher to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. The purpose of the validating a project is to document that the decisions made regarding the system have been properly designed, documented, executed, and verified. It is important to demonstrate that actions were properly planned, that the actions were executed according to the plan, and that the correct records have been kept so when the time comes, proof can be shown about the nessecarry vadlidation procedure. Validation is the responsibility of the business process owner. . Ultimately, upper management provides the resources for validation and what will be accepted once the system is validated. While an organization can utilize third parties to design and perform the validation, the responsibility for validation and the maintenance of a validated state cannot be delegated. Validation can be a longer term and complex activity. For complex projects the responsibilities and tasks are shared between several people. For example operations typically define and verify requirement specifications, the validation group may develop test cases and QA reviews the tests protocols. Typically validation is cross functional team activity with team members from all functions that are affected by the computer system. Persons who are responsible for the entire validation or specific tasks should be qualified for the assigned tasks. The qualification should be documented. For example, if a QA person develops test cases he/she should have a good understanding of the computer system and of the application. The person who develops test cases should have a good understanding about the computer system and about the application. Otherwise it is impossible to define critical test cases.
The main responsibility for validation of computer system lies with the end-users. They know their systems and the applications best and typically also have the highest interest that the system works reliably as intended. They have to be in control of their system. End-user representatives write the specifications, develop test cases and do most of the initial and on-going testing. They should get help from validation groups on technical content and from QA on the format of test protocols. People who test the software or computer system should represent different types of typical users. For example, if the computer system is used by low skilled operators, test personnel should include these type of operators. The person who develops the software or computer system should not be the only one who tests it. This should ensure objectivity of the test.
For software developed in-house the development department develops functional and design specifications, implements and reviews the code, and tests code modules. Activities follow a software development lifecycle. IT designs and installs the network infrastructure. They develop scripts for installation and install network components. They advice on risk assessment and extent of testing related to network infrastructure. I do not believe that IT should be responsible for system validation. Typically they do not know the processes and applications running on the system. Suppliers develop software following a documented software development lifecycle. They test each function of the computer system. Test cases should be traceably to functional and user requirement specifications. They provide documented evidence that the software has been developed in a quality assurance environment and has been validated during development. They also provide functional specifications of the software and computer system and give recommendations on how to prepare the site or the installation. Vendor also accept users for