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LSREL08-BP01 Incorporate validated redundancy into architecture design - Life Sciences Lens

LSREL08-BP01 Incorporate validated redundancy into architecture design

During the design phase, plan for redundancy across fault-isolated zones and validate that each component meets regulatory requirements. Qualification of secondary systems should not be an afterthought but part of the original architecture plan. Document design decisions to show how redundancy supports both technical reliability and regulatory obligations.

Desired outcome: Workloads remain available during component failures, and redundant systems are equally validated for adherence.

Common anti-patterns:

  • Treating secondary systems as non-validated backups rather than qualified components.

  • Adding redundancy late in design, creating gaps.

  • Documenting only the primary system in validation records.

Benefits of establishing this best practice: Improves confidence in availability without compromising regulatory expectations. Provides reproducible architectural evidence for audits.

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

Implementation guidance

When planning workload architecture, design for multi-zone redundancy from the start. Your validation protocols should explicitly include redundant components, not just primaries. For each architecture diagram and system description, demonstrate that redundant paths preserve the same adherence controls, including data capture and security safeguards. Qualification evidence should reflect the entire redundant system architecture as validated.

Implementation steps

  1. Define multi-AZ or multi-Region designs in your architecture blueprints and validate them in qualification testing.

  2. Document redundancy plans in your system design specifications and standard operating procedures.

  3. Use AWS services such as Amazon RDS Multi-AZ, Amazon S3 cross-region replication, or Elastic Load Balancing across multiple Availability Zones, verifying that validation records include both primary and redundant configurations.