
SOPs define the rules of working sequences in almost all stages of development and production:
Functional Specifications (FS)
Design Specifications (DS)
testing procedures
product release documents
product documentation
certificates
service guidelines
The SOPs have been written in accordance with the respective rules, containing all necessary information for the control and revision of QA documents.
The directory tree of SOP documents starts with SOP 100 "QA Fundamentals".

|
基本概念 |
| SOP's |
| Life Cycle Model |
| リファレンマテリアル |
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|
機器検定 |
| 21 CFR Rule 11 |
|
サポート |
| バリデーション |
|
インフォメーション |
| 文献 |
| ISO |


