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LSREL04-BP01 Map regulatory requirements to reliability controls - Life Sciences Lens
Implementation guidanceResources

LSREL04-BP01 Map regulatory requirements to reliability controls

Create a comprehensive mapping between applicable regulatory requirements (like GxP, 21 CFR Part 11, and GDPR) and your reliability controls. Document how each control satisfies specific regulatory requirements and maintain this mapping as regulations evolve. For example, if regulations require system availability of 99.9% for critical applications, implement and document the architecture decisions, monitoring systems, and recovery procedures that support this requirement.

Desired outcome: A clear, documented traceability matrix between regulatory requirements and implemented reliability controls that demonstrates adherence and guides architecture decisions. This mapping serves as evidence during audits and inspections while verifying that reliability measures directly address regulatory obligations.

Common anti-patterns:

  • Implementing reliability controls without considering regulatory requirements.

  • Failing to document how reliability controls satisfy specific regulations.

  • Not updating the mapping when regulations or system architecture changes.

  • Focusing only on technical controls without considering procedural and documentation requirements.

Benefits of establishing this best practice:

  • Provides clear evidence of regulatory adherence for audits and inspections.

  • Aligns reliability investments with regulatory priorities.

  • Facilitates impact assessment when regulations change.

  • Supports risk-based decision making for reliability investments.

Implementation guidance

Use AWS Config to track configuration changes that might affect adherence to regulatory requirements.

Consider implementing AWS Audit Manager to continuously audit your AWS usage to simplify risk assessment and adherence with regulations.

Implement tagging strategies to identify resources subject to specific regulatory requirements.

Use AWS Systems Manager documents to standardize and automate checks.

Implementation steps

  1. Identify the applicable regulatory requirements related to system reliability (like FDA, EMA, and ICH).

  2. Create a traceability matrix documenting each requirement and corresponding control.

  3. Use AWS Config to establish configuration rules that enforce regulatory requirements.

  4. Implement AWS CloudWatch alarms to monitor adherence to availability requirements.

  5. Document architecture decisions that support regulatory requirements using AWS Well-Architected Tool.

  6. Establish a review process to update the mapping when regulations or systems change.

Resources

Related best practices:

  • Implement comprehensive monitoring for regulated systems

  • Establish reliability qualification procedures

  • Design for fault isolation and  graceful degradation