Doc any modifications towards the SAT process and scope in a very revision heritage, which really should be taken care of and referenced all through the challenge.
A Site Acceptance Test (SAT) is usually a method utilized to verify that a technique meets the necessities of the customer or consumer. It will likely be executed at The shopper’s site following the program has actually been installed.
We thoroughly approach the site acceptance testing, together with defining test eventualities, outlining acceptance requirements, and determining assets demanded for that testing method.
To verify that the I/O Allocation configuration matches Along with the authorized I/O wiring desk / IO Allocation doc.
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Pre-test planning is essential. Make sure all needed tools and utilities can be found and tested upfront.
These areas mostly relate to features, security, Health and fitness to consumer demands, compliance in the program to GMPs, and facts integrity. It's common to find inconsistencies put up fabrication considering that you will discover options of misses for the duration of translation of all of the person requirement specifications (URS) and purchase get commitments into design and style/fabrication. An case in point is the use of a normal coated floor rather than a stainless-steel complete for environmental chambers. The solution influence might be minimum because it is strictly employed for storage of the device’s put up-secondary packaging. Having said that, there could possibly be an effect on the cleansing procedure Which may be used on-site. Generating these types of changes for the set up site is impractical; consequently, FAT is a must-do stage as opposed to awesome to carry out, for critical systems.
Present more diagrams or charts that site acceptance test protocol could enable make clear complex principles or techniques in the method.
Pro Suggestion: Incorporate a bit for observations or anomalies that will effect outcomes to provide additional context.
The target in the Factory Acceptance Test (Excess fat) is to verify the technique is about up properly and may work as predicted from each the hardware and configuration program viewpoint prior to it ships to the site.
The shopper’s purpose assures the operational atmosphere supports testing and that acceptance choices are determined by detailed reviews. Make sure to define the roles of every crew member associated with the SAT approach:
Addressing these common worries is crucial to preserving a easy and productive SAT approach. Without a doubt, by employing very clear scope boundaries, making certain finish facts, and fostering open up click here communication, testing teams can cut down the risk of delays and troubles.
Concerns might be rectified just before they have the probable to lead to harm or hurt, which also permits assignments for being kept on track and, if relevant, on price range.
Environmental conditions: temperature and humidity stages aren't a similar in the maker’s site as The seller’s site. Serious disorders of utilities, for example compressed air or steam, could only be delivered through the SAT for the proprietor’s site;