Compliance Frameworks

GxP EU Annex 11

gxp_eu_annex_11_aws

14 Requirements

24 Checks

Description

The GxP EU Annex 11 framework is the European equivalent to the FDA 21 CFR part 11 framework in the United States. This annex applies to all forms of computerized systems that are used as part of Good Manufacturing Practices (GMP) regulated activities. A computerized system is a set of software and hardware components that together fulfill certain functionalities. The application should be validated and IT infrastructure should be qualified. Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control, or quality assurance. There should be no increase in the overall risk of the process.

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Compliance Frameworks

GxP EU Annex 11

Description

Compliance MetadataEdit

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Requirements

Computerised systems exchanging data electronically with other systems should include appropriate built-in checks for the correct and secure entry and processing of data, in order to minimize the risks.8 Checks

Data should be secured by both physical and electronic means against damage. Stored data should be checked for accessibility, readability and accuracy. Access to data should be ensured throughout the retention period.22 Checks

Regular back-ups of all relevant data should be done. Integrity and accuracy of backup data and the ability to restore the data should be checked during validation and monitored periodically.8 Checks

For records supporting batch release it should be possible to generate printouts indicating if any of the data has been changed since the original entry.2 Checks

Any changes to a computerised system including system configurations should only be made in a controlled manner in accordance with a defined procedure.1 Checks

Management systems for data and for documents should be designed to record the identity of operators entering, changing, confirming or deleting data including date and time.2 Checks

Data may be archived. This data should be checked for accessibility, readability and integrity. If relevant changes are to be made to the system (e.g. computer equipment or programs), then the ability to retrieve the data should be ensured and tested.9 Checks

Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation process.1 Checks

The regulated user should take all reasonable steps, to ensure that the system has been developed in accordance with an appropriate quality management system. The supplier should be assessed appropriately.1 Checks

For the validation of bespoke or customised computerised systems there should be a process in place that ensures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of the system.1 Checks

If data are transferred to another data format or system, validation should include checks that data are not altered in value and/or meaning during this migration process.9 Checks