The process of software validation according to the ISO 9001 standard
According to the quality management system, validation is confirmation that the requirements for a specific use or application have been met. This confirmation is based on providing objective evidence (ISO 9000:2005).
The process of validation is carried out with the help of:
- worked out strategy and validation criteria for all ready products;
- specified actions on carrying out the validation;
- demonstration of the compliance of the developed software to the requirements of the customer and rules of their use;
- discussing the received validation results with the customer and approving them.
One of the major steps in a validation process is developing the validation master plan (VMP). This is the main document which works as the first step in any software validation project.
Software validation includes not only documented evidence of the software compliance to certain requirements but also covers the whole life cycle: from the concept to shutting down.
It is also necessary to mention the difference between validation and verification. Verification is the process of confirming that the developed software complies to the project documentation, in other words, is realized in accordance with the requirements.
The validation process is aimed at the work of users in the developed software. Validation gives the opportunity to check if the developed software allows to carry out the business process it was created for and to prove that the developed software leads to the expected results.