GMP关于计算机系统的法规

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EU GMP guide annexes - Supplementary requirements: Annex 11

Computerised Systems

1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? (H+V February 2011)

Templates of Spreadsheets helps to avoid erroneous calculations by data remaining from previous calculations. They should be suitably checked for accuracy and reliability (Annex 11 p7.1). They should be stored in a manner which ensures appropriate version control. (Chapter 4 p4.1)

2. Which type of accuracy checks (Annex 11 p 6) are expected for use of spreadsheets? (H+V February 2011)

Data integrity should be ensured by suitably implemented and risk assessed controls. The calculations and the files should be secured in such a way that formulations are not accidentally overwritten. Accidental input of an inappropriate data type should be prevented or result in an error message (e.g. text in a numeric field and or a decimal format into integer field) - so called boundary checks are encouraged.

3. Are there any specific considerations for the validation of spreadsheets? (H+V February 2011)

Validation according to paragraph 4 of Annex 11 is required at least for Spread-sheets that contain custom code (e.g. Visual basic for applications). Formulas or other types of algorithms should be verified for correctness.

4. Which measures are required to ensure data security of databases? (H+V February 2011)

Data security includes integrity, reliability and availability of data. During Validation of a database based/inclusive systems considerations should be given to the following

∙Implementing procedures and mechanisms to ensure data security and keeping the meaning and logical arrangement of data.

∙Load testing taking into account future growth of the database and tools to monitor the saturation of the database.

∙Precautions for necessary migration of data (Annex 11 p17) at the end of the lifecycle of the system.