使用西门子Simatic WinCC高效实施遵从FDA 21 CFR Part11规范的系统

Use Simatic WinCC to Implement the Requirements of FDA

由于食品行业不断出现威胁生命安全的问题，药物，食品，饮料和烟草等行业的生产流程必须遵从特定的法规也就变得势在必行。这些行业的生产流程必须确保只有授权人员才能够对制造流程进行修改，另外，必须能够记录每一次的修改，并且对修改行为所做的记录将无法再被修改。

Scandals in the food industry have led to the manufacturing processes in the pharmaceutical and food, beverages and tobacco industries having to comply with specific legal requirements. It must be ensured, for example, that only authorized people are allowed to make changes in the manufacturing process. In addition, you must be able to log each change on an unchangeable basis. A production facility must be validated before it is put into operation. When this is done, recognized inspectors check that the stipulations have been complied with.