Qualified infrastructure, automated evidence, and guardrails that keep validated systems compliant without turning every release into a validation project.
Traditional computer system validation ties compliance cost to release frequency. The more often you ship, the more documentation each release carries, so teams ship less often and modernization slows.
Installation qualification built from screenshots and spreadsheets is slow to produce and out of date as soon as the infrastructure underneath it changes.
Point-in-time validation confirms the environment was compliant on a particular date. Continuous evidence covers the weeks in between.
We build AWS environments where compliance evidence is a byproduct of how the infrastructure runs, so your QA team reviews evidence instead of assembling it.
Multi-account AWS environments defined entirely in code, with the boundary between GxP and non-GxP workloads made explicit. Every environment reproducible, every change reviewable, every deployment traceable.
Control Tower guardrails and Service Control Policies that stop non-compliant changes before they happen. Read-only console access in production, with changes flowing only through approved pipelines.
Resource configuration captured continuously and compared against an approved specification, so qualification evidence is generated instead of assembled. Traceability runs from a change to the record of it.
Drift detection against your qualified baseline, with dashboards showing the state of the environment now, not at the last audit.
We build and operate the infrastructure. Validation decisions stay with your quality organization; we make the evidence they depend on cheaper and more reliable to produce.
AWS documents the reference architecture behind this approach in detail on the AWS Industries Blog. GxP Continuous Compliance on AWS
Control implementation and evidence automation across FedRAMP and FedRAMP 20x, NIST, CMMC, HECVAT, FERPA, TX-RAMP, SOC 2, HIPAA, and GxP standards.
Containers on ECS and EKS, serverless adoption, CI/CD and delivery automation, Infrastructure as Code, and application refactoring.
We'll review your current AWS setup alongside your quality system and show you where automation can take work off your QA team without loosening a single control.
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