If you work at a regulated company, then there is a fair chance that you have heard of the term computer system validation (CSV). The issue is that a “computer system” is technically the hardware and software of a platform system. Around that you need to add application software, ancillary equipment, people and procedures to form a “computerised system”. This computerised system then runs within a company’s operating infrastructure (or on a hosted cloud if run within a cloud-hosted service environment).
Each of these elements within the computerised system need to be either validated or qualified.
Validation is providing evidence-based proof that a process will consistently produce a result meeting its predetermined specifications and quality attributes.
Qualification is proving that some physical entity is fit for its intended use as defined in a set of requirements.
Total automated solutions usually comprise of several distinct validation and qualification exercises that come together in a final performance qualification (PQ) or user acceptance test.
These days, very few automated solutions run independently on a standalone hardware device segregated from any other node on the network.
A node is any physical device on a computer network that is able to send, receive and/or forward information.
For this reason, network infrastructure that supports the computerised system also needs to be qualified/validated. Individual components are qualified then the network as a whole is validated.
In a perfect world, this would be done and maintained independently of the computerised system, and then just updated or referenced whenever a new computerised system is added or updated.
In a common real-world scenario (where your computer infrastructure is being suitably managed but not formally validated), the infrastructure components addressed or utilised as part of a project, can be separately qualified/validated as part of that defined automated system project.
This is a good approach for a single project but is not a sustainable approach as more and more computerised systems require validation.
Obviously, it is better to have a known validated network infrastructure and simply reference this as each automated system project utilises components and processes on the network.
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