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EU GMP Annex 11

The European Union Good Manufacturing Practice (GMP) Annex 11 provides guidance on computerized systems used in pharmaceutical manufacturing and quality control. This regulation, enforced by the European Medicines Agency (EMA), establishes requirements for validation, data integrity, and electronic record management in pharmaceutical operations. It applies to all pharmaceutical manufacturers operating within the European Union and those exporting to EU markets.

Terraform Registry Subdomain: eugmpannex11

module "..." {
  source  = "eugmpannex11.compliance.tf/terraform-aws-modules/<module>/aws"
  version = "<version>"
}

module "..." {
  source = "https://eugmpannex11.compliance.tf/terraform-aws-modules/<module>/aws"
}

Refer to the Terraform Registry Endpoints section for more details.

Implemented Controls

The following controls are implemented as part of this framework.

Enable/Disable Controls

You can customize the Terraform module for the desired compliance requirements by enabling/disabling individual controls.

Examples

S3 bucket module with EU GMP Annex 11 compliance framework controls enabled, and a couple of controls disabled

module "..." {
  source = "https://eugmpannex11.compliance.tf/terraform-aws-modules/s3-bucket/aws?disable=apigateway_stage_cache_encryption_at_rest_enabled,backup_plan_min_retention_35_days"
}