Solution  BY  Communication  | Language: Chinese
Audit Guide
10.1 Whether or not the establishment of a computer management system of post operation functions and procedures? 
10.2 Whether the existing automation or computer for classification, and developed the corresponding verification plan?
10.3 Whether for pharmaceutical manufacturing equipment automation system to complete the test validation, ensure that it can obtain reliable results? 
10.4 Whether to have the complete records of verification, and the verification report, and archiving? 
10.5 If there is a suitable method to prevent unauthorized personnel cannot for data input, such as an encryption key, guide the card, the personal password and idle access to computer terminals? 
10.6 For a computer system and software are changes to establish procedures, including changes of verification, examination, approval and Implementation? 
10.7 If you can get a clear print copies of electronically stored data, in order to satisfy the audit requirements? 
10.8Electronic records are safe, not lost, destroyed or unauthorized change? 
10.9 If the computer equipment or software is changed, whether to take necessary protection and examination room or electronically stored data? 
10.10 Whether a data protection measures, avoid data burst fracture? 
10.11 Whether to check the accuracy of the data, the easy availability and persistence? 
10.12 If the data are regularly backed up? And the backup data stored in isolation of the safe area? 
10.13 Whether to establish a routine maintenance procedures and records? 
10.14 Whether the strict implementation of the automation or computer system maintenance operation procedure and records? 
10.15 Are inspection and processing system fault related procedures?
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