21_cfr_part_11
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21_cfr_part_11 [2022/01/17 13:53] yves |
21_cfr_part_11 [2022/01/17 13:56] yves |
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| + | ===== 21 CFR part 11 compliance ===== | ||
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| PMA.core was developed with the [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application|FDA 21 CFR part 11 guidelines]] in mind. | PMA.core was developed with the [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application|FDA 21 CFR part 11 guidelines]] in mind. | ||
| - | Our software adhere to the following principles: | + | Our software adheres to the following principles: |
| * Data will be formatted to allow transfer to another system for long-term storage in a common portable format either during the life of the system or after the system is retired | * Data will be formatted to allow transfer to another system for long-term storage in a common portable format either during the life of the system or after the system is retired | ||
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| * If it is important to system functionally that steps be performed in a specified order, the system will contain a mechanism to ensure that actions are performed in the correct sequence (in case of sequenced steps) | * If it is important to system functionally that steps be performed in a specified order, the system will contain a mechanism to ensure that actions are performed in the correct sequence (in case of sequenced steps) | ||
| * The system will contain an automatically generated [[audit trail]] function for all process significant and GxP critical events and allow audit trails on tables and individual records | * The system will contain an automatically generated [[audit trail]] function for all process significant and GxP critical events and allow audit trails on tables and individual records | ||
| - | The audit trail data will be read-only | + | * The audit trail data will be read-only |
| - | It will be impossible to disable the audit trail function | + | * It will be impossible to disable the audit trail function |
| * The system will prevent the accidental or intentional modifications or deletion of audit trail files | * The system will prevent the accidental or intentional modifications or deletion of audit trail files | ||
| * It will be possible to generate a report to view which data in the record has been modified | * It will be possible to generate a report to view which data in the record has been modified | ||
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| * If a password is not issued privately (i.e. the password issuer knows the password), the user will immediately reset their password | * If a password is not issued privately (i.e. the password issuer knows the password), the user will immediately reset their password | ||
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| + | [[https://www.wikipedia.org|Wikipedia]] has [[https://en.wikipedia.org/wiki/Title_21_CFR_Part_11|more background on this topic]]. | ||
21_cfr_part_11.txt · Last modified: 2022/03/29 16:03 by yves
