Now, let us understand more about each of these 3 phases in detail. Sometimes due to time constraints, PQ can start in parallel to OQ, once the key aspects of OQ are established.
PLC PROCESS 3 STAGES SOFTWARE
Unless the installation is done, the functionality of the software cannot be verified and unless the functionality is proven, no point in measuring the performance. Ideally, IQ, OQ, and PQ are sequential activities, which need to be executed in order.
Overall, the purpose of carrying out IQ, OQ, and PQ is to ensure that the software can be successfully deployed and all the functionalities can be used without any bottlenecks. Summary reports will be handed over to Ops Team during the software handover along with the binaries and other deliverables. The template, plan, and any other documents which are input to carry out the 3Qs, will be laid out by the Software Team for their software and it includes the detailed approach, tasks/activities/tests to be conducted as a part of these qualifications along with the test results. Given below is the Validation Process Flow Diagram: However, in the software context, the 3Q’s approach, IQ-OQ-PQ is being followed as part of Validation and it will be carried out by the Operations team, who are ultimately responsible for deploying the software to production. The constituents of the Validation activities for software is to prove that ‘the software is ready for consumption by the users’, and to mainly verify the successful installation of the software followed by the functionality and operability. Here validation will be done by the end customer before buying the machinery, equipment, or product. This 5 phase approach of the Validation process is being followed in many Industries like Manufacturing, Medical, Pharmaceuticals, etc. And hence the validation process is broken down into 5 Phases. Generally, the Validation Process of any product refers to the complete life cycle of a product from development through use and maintenance. Hence, in the case of Application Development, it is the Ops Team that is carrying out the Validation activities for the software. Validation activities are mostly carried out at the production site. Whereas ‘ Validation’ is a set of quality assurance checks which are carried out by the external customers, owners, and vendors on the product being delivered to them, to check the suitability before accepting or purchasing the product. ‘ Verification’ is to evaluate the software with respect to the given set of requirements and specifications which is done in-house at the Software Development site by the Developers and Testers. Here let’s clearly understand the difference between ‘Verification’ and ‘Validation’ activities.
PLC PROCESS 3 STAGES VERIFICATION
Once the verification is completed and the software is signed off by the Program/Product team, Ops Team would carry out a set of activities before accepting the software to be deployed to production, to prove that the software is behaving as expected, which is nothing but the validation activities. This is where the validation of the software comes into the picture. Now, here lies the real challenge for the Operations Team to make the software function in the production environment, because, during the software development phases, development and verification has been done in a simulated environment, and quite rarely close to the live environment, only in case of availability of data and configurations of the production environment. Further, it is the Operations Team (generally referred to as Ops Team) that takes care of deploying it to a production environment and make it ready to be used by the end-users. With this approach of SDLC, the Software Development Team generally washes off their hands by handing over the completed software (developed and verified) to the Operations Team.
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