What is GxP and GAMP?
GxP is a set of quality guidelines designed to ensure a product is safe, and meets quality standards, often in fields relating to life sciences and pharmaceuticals. GAMP (Good Automated Manufacturing Practice) offers structured guidelines for validating automated systems. It emphasizes risk-based validation, documentation, and testing, ensuring consistency, regulatory compliance, and high-quality product production.
Aligning GxP and GAMP compliance on AWS
Change Management
Tools like Terraform and AWS CloudFormation to automate deployments and configuration management. By codifying your infrastructure and making it version controlled you can ensure consistency and reproducibility, which enables you to have a lightweight change management system.
Validation and Documentation
Apply validation steps to your infrastructure-as-code and document your processes to ensure that it complies with GxP regulations and GAMP.
Monitoring and Auditing
Use services such as AWS CloudTrail, AWS GuardDuty, AWS Control Tower to monitor, log, and report on activities within your AWS environment. This will allow you to demonstrate the effectiveness of your QMS during audits.
Achieving GxP (Good X Practice) and GAMP (Good Automated Manufacturing Practice) compliance on AWS involves establishing a comprehensive and regulatory-compliant framework for quality management and automated systems within the AWS cloud environment. Key considerations include validation of cloud-based systems, secure access controls, change management, audit trails, data encryption, backup and recovery plans, supplier/vendor assessments, and ongoing monitoring and reporting. By leveraging AWS's secure and compliant infrastructure, you can create GxP and GAMP-compliant environments to ensure the quality and regulatory compliance of your products and services.
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