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LSOPS04-BP02 Enforce controls in IT tooling and automation - Life Sciences Lens

LSOPS04-BP02 Enforce controls in IT tooling and automation

Implement quality controls and automation in the standard IT tooling used by the development teams whenever possible to enable continuous validation.

Desired outcome:

  • Automated enforcement of quality and regulatory controls within development workflows.

  • Reduced manual oversight burden while maintaining regulatory adherence.

  • Early detection of regulatory issues during the development process.

Common anti-patterns:

  • Relying primarily on manual reviews and approvals for verification.

  • Inconsistent application of controls across different teams or environments.

  • Adding audit checks only at the end of development cycles.

Benefits of establishing this best practice:

  • Increased development velocity through automated audit verification.

  • Improved quality through consistent application of controls.

  • Greater scalability of processes across growing organizations.

Level of risk exposed if this best practice is not established: Medium

Implementation guidance

Identify key control points in your development and operational processes where automated verification can replace manual checks. Implement infrastructure as code templates with pre-validated configurations, automated testing for regulatory requirements, and continuous monitoring for drift from approved baselines. These automated controls should generate appropriate evidence for audit purposes while remaining transparent to developers.

Consider an automated approach where you translate regulatory requirements into automated tests and policies. This allows teams to validate adherence continuously throughout the development lifecycle rather than as a separate activity. When properly implemented, automated controls can provide greater assurance than manual processes while reducing the compliance burden on teams.

Implementation steps

  1. Identify key control points in development and operational workflows:

  • Use AWS Glue Data Quality for data pipelines.

  1. Integrate automated testing into CI/CD pipelines:

  • Use AWS CodePipeline with validation gates.

  • Use AWS CodeBuild for running automated tests.

  1. Deploy continuous monitoring solutions for configuration drift:

  • Use AWS Config Rules to detect non-compliant resources.

  • Use Amazon EventBridge for automated remediation of issues.

Resources

Related documents:

Related examples:

Related tools: