LSREL13-BP01 Implement comprehensive monitoring for regulated systems
Establish monitoring that spans infrastructure, applications, data integrity, and audit controls. For GxP systems, verify that your monitoring covers validation-critical parameters identified in risk assessments, so that regulated workloads can demonstrate continuous oversight.
Desired outcome:
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Holistic visibility into workload health and reliability.
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Early detection of anomalies across infrastructure and applications.
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Assurance that monitoring captures validation-critical parameters in GxP systems.
Common anti-patterns:
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Monitoring only infrastructure without application or data-level coverage.
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Relying on reactive alerts instead of proactive anomaly detection.
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Lack of defined monitoring scope for regulated workloads.
Benefits of establishing this best practice:
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Enables quick response before failures impact experiments or studies.
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Provides audit-ready evidence of system oversight for regulators.
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Improves researcher trust in system stability and availability.
Level of risk exposed if this best practice is not established: High
Implementation guidance
Design monitoring across layers, including infrastructure (compute, storage, network), application (latency, errors, throughput), and data integrity. Incorporate health checks aligned with business priorities. Define thresholds for alerting and automate incident response workflows. Retain monitoring records in adherence to retention and audit requirements.
Implementation steps
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Instrument workloads with Amazon CloudWatch metrics, alarms, and dashboards.
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Capture logs centrally in Amazon CloudWatch Logs.
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Use AWS X-Ray for distributed tracing of microservices.
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Monitor configuration drift with AWS Config and events with AWS Security Hub CSPM.
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Store monitoring evidence in Amazon S3 for regulatory audits.
