GxP Cloud Compliance

Driftly: Your cloud infrastructure. Always audit-ready.

Continuously checks your AWS resources against versioned, approved GxP baselines, detects configuration drift the moment it happens and generates audit-ready evidence on demand.

21 CFR Part 11 · GAMP 5 · EU Annex 11 · SOC 2 / HIPAA

The problem

Your validated cloud changes every day. Your quarterly review does not.

  • Manual audits can't keep up. Quarterly reviews take weeks and check yesterday's configuration.
  • Generic security tools don't speak GxP. CSPM scanners check CIS security benchmarks, not your validated baselines, Part 11 controls or internal SOPs.
  • Inspectors want evidence now. When an inspector asks for the cloud change log and compliance status, you need answers in minutes.
  • Validation pressure. Every undocumented change puts the validated state of your GxP workloads at risk.
Capabilities

What Driftly does

Real-time drift detection

AWS CloudTrail events trigger a check on every resource change — from event to compliance alert in under 60 seconds.

Versioned, approved baselines

Baselines carry a full lifecycle with approval workflow, inheritance and overrides — 20+ comparison operators across 20+ AWS resource types.

AI bootstraps, humans govern

AI drafts baselines for new resource types from best practice; your compliance team reviews and approves. Production checks are deterministic — no AI in the runtime loop.

Audit-ready evidence

Every result is stored with full traceability. Alerts go to email, Microsoft Teams or SNS, and reports are ready for an inspector.

Multi-account view

One dashboard across development, staging and production accounts via cross-account roles.

Lighter validation effort

A GAMP 5 Category 4 configurable product, so validation focuses on configuration verification — reducing your IQ/OQ/PQ effort.

How it works

Four steps from signal to evidence

  1. Detect

    CloudTrail events trigger the pipeline on every resource change.

  2. Extract

    The full resource configuration is pulled through AWS APIs.

  3. Compare

    Every field is checked against your approved baseline.

  4. Report

    Results are stored with traceability and alerts go to your team.

Who it's for

Built for regulated teams

  • Pharma, biotech and medical device companies running GxP workloads on AWS
  • Heads of IT Compliance and QA, CISOs and VPs of Engineering
  • Regulatory Affairs and CSV/validation teams
  • Teams facing an inspection, a cloud migration or heavy validation workload
Where it runs

Deployment

Deployed with infrastructure-as-code into your own AWS account and VPC — configuration data, results and reports never leave your network boundary. Fully serverless: no agents, no sidecars, nothing to patch. Initial deployment takes about 30 minutes; full onboarding takes one to two business days.

FAQ

Common questions

We already use Wiz or Prowler. Do we need Driftly?

Driftly is complementary. CSPM tools cover security posture; Driftly covers regulatory compliance against your validated GxP baselines. Most regulated teams run both.

Does any data leave our AWS account?

No. Driftly runs entirely inside your account and VPC with zero data egress.

Is there AI in the compliance checks?

No. AI only helps draft new baselines for human approval. Every production check is deterministic and repeatable.

How long does it take to get started?

About 30 minutes for the initial deployment and one to two business days for full onboarding.

See Driftly in a live 30-minute demo

Bring your questions — we'll show you how it works in a GxP environment like yours.

Book a demo

Also from Adept LSS: Data IntegrityIQ — gxp data integrity and ComplyIQ Pro — gxp training & competency.