Facility Monitoring Systems Validation: A Practical Approach 2

An FMS will typically include several monitoring devices: temperature, humidity, and pressure sensors or transducers, and perhaps velocity sensors and particle counters as well. It may also include digital devices for monitoring vacuum pumps or machine running states and feature digital outputs for alert/alarm indicators such as lights or sirens, and for other control functions.

The most important document for any proposed system is the User Requirement Specification (URS). Without this document, it is impossible to validate a system. This may come as a surprise to some, but validation is defined as no more—or less—than the process of generating documented evidence to provide a high degree of assurance that a system will consistently fulfill its stated function.
The URS states the required functions of the system. It need not be lengthy, but it must state the functions the system is to fulfill. Despite its name, it is not necessary for the user to generate the URS; the supplier can generate the document, but the URS must be authorized by the user. Its purpose is to ensure that both the user and the supplier understand what is required. The document should have a list of must-haves, want-to-haves, and would-be-nice-to-haves. The supplier must provide all the must-haves, but not necessarily the want-to-haves and the nice-to-haves.
From the URS, all other validation documents and stages then follow. This progression is normally shown in the form of the practical Validation Model (V-model) described in this article. These documents and processes are referred to as the Life Cycle Documents.
After the URS, the next step is for the supplier to generate a Functional Specification (FS). This document, which must address all the user’s must haves, want to haves, and would be nice to haves, should be generated before order placement. If some requirements cannot be met, as will inevitably be the case, the non-compliances must be listed within the FS. Quite often the requirement can be fulfilled in a different way; sometimes, the requirement is not even essential. The FS should include a cross-reference matrix so that the user can easily see how the supplier proposes to meet each requirement.

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