21_cfr_part_11
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21_cfr_part_11 [2022/01/17 13:53] yves |
21_cfr_part_11 [2022/03/25 19:13] 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 | ||
| * The system will contain detection mechanisms for invalid field entries, values out of range, and blank fields if entry is required | * The system will contain detection mechanisms for invalid field entries, values out of range, and blank fields if entry is required | ||
| - | * It will be possible to provide regulatory agenties with both human-readable and electronic copies of the records, including metadata. It will be possible to transfer data in a human readable format onto transportable media such as PDF, XML, SGML. The system must allow that the copying process produces copies that preserve the content and meaning of the records | + | * It will be possible to provide regulatory agencies with both human-readable and electronic copies of the records, including metadata. It will be possible to transfer data in a human readable format onto transportable media such as PDF, XML, SGML. The system must allow that the copying process produces copies that preserve the content and meaning of the records |
| * 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_trailing|audit trail]] function for all process significant and GxP critical events and allow [[audit_trailing|audit trails]] on tables and individual records |
| - | The audit trail data will be read-only | + | * The [[audit_trailing|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_trailing|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_trailing|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 | ||
| * A mechanism will be in place to detect and report any attempts of unauthorized use immediately to the customer | * A mechanism will be in place to detect and report any attempts of unauthorized use immediately to the customer | ||
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| * The system will not allow changes in date and time by the user | * The system will not allow changes in date and time by the user | ||
| * The system date and time will be periodically checked and corrected. The system will support time synchronization | * The system date and time will be periodically checked and corrected. The system will support time synchronization | ||
| - | * The electronic audit trails will be readily available for review | + | * The [[audit_trailing|electronic audit trails]] will be readily available for review |
| * The system will be protected against unauthorized use | * The system will be protected against unauthorized use | ||
| * Security will consist of at least two elements (e.g. login ID and password) in case of non-biometric security | * Security will consist of at least two elements (e.g. login ID and password) in case of non-biometric security | ||
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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
