Those performances should really mainly guarantee product defense, staff protection and environmental protection.
Let us have a look at how the lower-layer constraints of the instance protocol might be specified in PROMELA. We
totype of an implementation. In Area four we demonstrate how correctness requirements may be expressed within the
工艺确认阶段评估和验证早期设计的工艺，以确保其能够再现一致且可靠的质量水平。它涉及收集和评估有关制造过程各个方面和各个阶段的数据。这包括：
Making sure that the item is usually properly transported within just the specified temperature profile Which compliance with regulatory requirements as well as the anticipations of intrigued functions could be shown:
six. All of the controlling devices need to be calibrated and Qualified as per penned techniques that they're exact, precise, selective and distinct.
The linearity of an analytical treatment is its potential (in a offered selection) to get check final results, which might be directly proportional for the focus of analyte inside the sample at the LOQ degree.
rectness of our alternatives. here To show the critical click here Qualities of our design we have to prove, if possible
sages despatched to entire queues must be discarded.) ‘‘Executability’’ is usually a central principle in PROMELA, along with the
In Polybius’ days, the problem was to find a fantastic method for encoding and communicating an unexpected
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mated Instrument termed SPIN for mechanically verifying the validity of correctness needs, and give some
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需要指出的是，尽管早期工艺设计不需要根据 cGMP的标准展开，但同样应在合理的科学原则指导下进行。应遵循良好的文档规范。特别是记录工艺开发与优化工艺中的数据、观察与结论。