GxP (Good Practices) EU Annex 11

gxp_eu_annex_11_aws

GxP-EU-Annex-11

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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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Requirements (14)

General12

1-risk-managementRisk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system.2

Attributes

Item Id: 1-risk-management
Section: General
Service: aws

Operational Phase945

5-dataComputerised 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.5

Attributes

Item Id: 5-data
Section: Operational Phase
Service: aws

7.1-data-storage-damage-protectionData 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.18

Attributes

Item Id: 7.1-data-storage-damage-protection
Section: Operational Phase
Service: aws

7.2-data-storage-backupsRegular 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.5

Attributes

Item Id: 7.2-data-storage-backups
Section: Operational Phase
Service: aws

8.2-printouts-data-changesFor 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

Attributes

Item Id: 8.2-printouts-data-changes
Section: Operational Phase
Service: aws

9-audit-trailsConsideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated 'audit trail'). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed.2

Attributes

Item Id: 9-audit-trails
Section: Operational Phase
Service: aws

10-change-and-configuration-managementAny changes to a computerised system including system configurations should only be made in a controlled manner in accordance with a defined procedure.1

Attributes

Item Id: 10-change-and-configuration-management
Section: Operational Phase
Service: aws

12.4-security-audit-trailManagement 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

Attributes

Item Id: 12.4-security-audit-trail
Section: Operational Phase
Service: aws

16-business-continuityFor the availability of computerised systems supporting critical processes, provisions should be made to ensure continuity of support for those processes in the event of a system breakdown (e.g. a manual or alternative system). The time required to bring the alternative arrangements into use should be based on risk and appropriate for a particular system and the business process it supports. These arrangements should be adequately documented and tested.5

Attributes

Item Id: 16-business-continuity
Section: Operational Phase
Service: aws

17-archivingData 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.5

Attributes

Item Id: 17-archiving
Section: Operational Phase
Service: aws

Project Phase48

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

Attributes

Item Id: 4.2-validation-documentation-change-control
Section: Project Phase
Service: aws

4.5-validation-development-qualityThe 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

Attributes

Item Id: 4.5-validation-development-quality
Section: Project Phase
Service: aws

4.6-validation-quality-performanceFor 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

Attributes

Item Id: 4.6-validation-quality-performance
Section: Project Phase
Service: aws

4.8-validation-data-transferIf 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.5

Attributes

Item Id: 4.8-validation-data-transfer
Section: Project Phase
Service: aws