21 CFR Part 11 常见问题回答 (FAQ) - 梅特勒-托利多

21 CFR Part 11 常见问题回答 (FAQ)

梅特勒-托利多STARe软件V16.00版本的评估中,顾客和供应商的角色和职责包括:
  • 21 CFR 11 参照软件选项

为了遵守21 CFR第11章的规章要求
(电子档案和电子签名是最终要遵守的规章制度)


这个文件主要是为了描述21 CFR 11评估的角色和职责以及如何去遵循并完成它们,并告知顾客梅特勒-托利多在当前的规章制度下是如何回应挑战的。 

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