Please note that this post, first published over a year ago, may now be out of date.
In the rapidly evolving pharmaceutical and life sciences industries, maintaining compliance with regulatory guidelines is paramount. Good x Practice (GxP) and Good Automated Manufacturing Practice (GAMP) regulations provide the framework for ensuring the quality, safety, and integrity of products and processes.
As organisations increasingly adopt cloud technologies for their operations, they must extend GxP/GAMP compliance to their cloud environments. In the landscape of Amazon Web Services (AWS) Control Tower offers a robust solution to achieve this. AWS Control Tower streamlines the process of establishing and governing a secure, compliant, and multi-account AWS infrastructure. In this blog post, we explore how AWS Control Tower assists in meeting GxP/GAMP compliance requirements, focusing on security and access controls.
Account baseline configuration for GxP compliance
AWS Control Tower enables you to define a GxP-compliant baseline configuration for new AWS accounts. With this capability, you can ensure that all newly created accounts start with essential security settings, such as strong password policies, multi-factor authentication (MFA), and logging options. This baseline configuration lays the foundation for a secure cloud environment that aligns with GxP standards.
Guardrails for GxP security
Control Tower introduces “controls” – predefined rules and policies designed to enforce GxP security best practices. These controls cover crucial areas like data encryption, access control, network security, and audit logging. By enabling and enforcing these controls, you can maintain a secure and compliant cloud environment for GxP/GAMP workloads, mitigating potential risks and vulnerabilities.
IAM permissions boundaries for least privilege
In GxP and GAMP compliance, adhering to the principle of least privilege is critical to restricting access to sensitive data and critical systems. AWS Control Tower allows you to set IAM permissions boundaries, ensuring that users and roles in AWS accounts have only the necessary permissions required for their GxP-related tasks. This granular control reduces the risk of unauthorised access and potential security breaches.
GxP-compliant account vending machine
AWS Control Tower’s account vending machine feature allows you to create new AWS accounts with predefined GxP-compliant configurations. This includes setting up role-based access control (RBAC) and ensuring segregation of duties – essential requirements in GxP environments. The account vending machine ensures consistent and secure account creation across the AWS infrastructure.
Centralised governance for GxP compliance
Control Tower provides a central management dashboard for monitoring and enforcing GxP-related policies and controls across multiple AWS accounts. This centralised governance approach helps you maintain consistent security measures, access controls, and configurations required for GxP/GAMP compliance. It ensures that all accounts in the AWS environment adhere to the same high standards.
Security audit and compliance monitoring
AWS Control Tower facilitates the creation of dedicated audit accounts to store logs and monitor security events across the AWS environment. These logs play a crucial role in compliance audits and help you demonstrate adherence to GxP regulations. Comprehensive auditing and monitoring ensure that any security breaches or anomalies are promptly identified and addressed.
As the pharmaceutical and life sciences industries embrace cloud technologies for increased efficiency and scalability, ensuring GxP/GAMP compliance in the cloud is of paramount importance. AWS Control Tower serves as a valuable foundation, providing essential tools and features to meet security and access control requirements specific to GxP and GAMP. By leveraging Control Tower’s capabilities, you can confidently build, manage, and secure your cloud environments while adhering to the stringent regulations that govern your industry. This not only ensures the quality and safety of products and processes but also maintains the trust and confidence of stakeholders and regulatory bodies alike.
Are you GxP / GAMP ready? Do you have an effective quality management system and processes that deliver the right technical controls in your AWS environment?
Our AWS Readiness Assessment provides a quick expert check and report of your infrastructure against the GAMP IT Infrastructure Control and Compliance guide. Book yours now or book a free chat with us to discuss this further.
This blog is written exclusively by The Scale Factory team. We do not accept external contributions.
