This rule ensures that DynamoDB table is safeguarded by a backup plan to prevent data loss.
Rule | DynamoDB table should be protected by backup plan |
Framework | GxP EU Annex 11 |
Severity | ✔ High |
Rule: DynamoDB Table Backup for GxP EU Annex 11 Compliance
Description of the Rule
Background
Good Practices for pharmaceuticals, commonly known as GxP, encompasses various aspects of compliance in the pharmaceutical industry, including the EU Annex 11, which provides guidance on computerized systems. One essential requirement is to ensure that critical data, such as those stored in AWS DynamoDB tables, is regularly backed up and protected against loss.
DynamoDB and GxP EU Annex 11 Compliance
Ensuring that AWS DynamoDB tables are regularly backed up is crucial for maintaining data integrity, availability, and security. This complies with the requirements of GxP EU Annex 11 that call for meticulous data management and protection strategies.
Troubleshooting Steps
If a DynamoDB table is not backed up correctly, follow these troubleshooting steps:
Necessary Codes and CLI Commands
Enable Automatic Backups Using AWS CLI
aws dynamodb update-continuous-backups \ --table-name <YourTableName> \ --point-in-time-recovery-specification PointInTimeRecoveryEnabled=true
Replace
<YourTableName>
with the name of your DynamoDB table.Create an On-Demand Backup Using AWS CLI
aws dynamodb create-backup \ --table-name <YourTableName> \ --backup-name <YourBackupName>
Replace
<YourTableName>
with the name of your DynamoDB table and <YourBackupName>
with the desired backup name.Step by Step Guide for Remediation
By following these steps, you can ensure that your DynamoDB tables are backed up in compliance with GxP EU Annex 11 and protect critical pharmaceutical data. Remember, successful adherence to GxP regulations necessitates both technological and procedural safeguards to maintain data integrity and availability.