4-Week FDA Audit Cycle Cut to Hours by Embedding Compliance Into Every Build
A large pharmaceutical enterprise running 60+ containerised services on OCI Kubernetes Engine under FDA 21 CFR Part 11 had security scanning disconnected from the build pipeline – vulnerable images could reach OKE before scans completed. Audit preparation consumed 3-4 weeks per cycle, no SBOM generation existed, secrets were hard-coded across services, and the CISO had zero real-time compliance visibility. Applying its AI-First approach, Ksolves embedded Trivy, SAST, SBOM generation, and OCI Vault rotation into every Dagger build making compliance a by-product of every pipeline run, not a 4-week fire drill.
Key Challenges
01
FDA Audit Prep Consuming 3-4 Weeks: Collecting scan evidence, pipeline logs, SBOM artefacts, and rotation records from fragmented tools pulled senior engineers entirely off product work every audit cycle.02
No Unified Vulnerability View: Scanning fragmented across multiple tools with results in different systems, CISO had no consolidated compliance posture across 60+ services at any point in time.03
Security Scanning Off the Build Pipeline: Trivy, SAST, and dependency checks ran manually on an ad-hoc schedule vulnerable images could reach OCIR and OKE before any scan was complete.04
Hard-Coded Secrets With No Rotation Policy: Secrets inconsistently managed - some hard-coded in config files, others in OCI Vault without automated rotation - creating audit gaps in a regulated environment.05
No SBOM Per Build: No automated SBOM generation meant component lineage required manual reconstruction per audit - failing FDA 21 CFR Part 11 and supply chain compliance requirements.06
Compliance Posture Invisible to Leadership: CISO and VP Engineering relied on manually compiled spreadsheets outdated before distribution with no real-time CVE counts, DORA metrics, or RAG status.Our Solution
Ksolves embedded security scanning, SBOM generation, and OCI Vault rotation into every Dagger build, turning compliance evidence into a build artifact. A custom Backstage dashboard delivers real-time security and delivery insights for 60+ services.
- 01 5-Stage Security Gate on Every Build: Every Dagger build runs SAST, Trivy scanning, dependency checks, SBOM generation, and OCI Vault rotation in sequence, no image reaches OCIR unless all five pass.
- 02 Trivy Scanning as a Build Gate: Every container image scanned before OCIR push - critical/high CVEs block the build, findings logged to OCI Logging linked to the pipeline run and Git commit.
- 03 Automated SBOM Per Build: SBOM generated for every image capturing all component versions, licences, and dependencies - stored immutably in OCI Object Storage for FDA 21 CFR Part 11 traceability.
- 04 OCI Vault - Zero Hard-Coded Secrets: Pipeline validates no hard-coded secrets before proceeding. Automated rotation triggered per build, every rotation logged to OCI Audit as tamper-proof compliance evidence.
- 05 Custom Backstage Compliance Dashboard: Per-service RAG indicators, live CVE counts, SAST summaries, DORA metrics, and OCI Audit trail links - CISO sees the full 60+ service posture in one always-current view.
- 06 OCI Logging and Audit - Tamper-Proof Evidence: All pipeline runs, scan results, rotations, and deployments recorded in OCI Audit - every production deployment traceable to its SBOM, scan record, and Git commit.
Solution Architecture
Technology Stack
| Category | Technology |
|---|---|
| CI/CD | Dagger |
| Security | Trivy + SAST Tools |
| Platform | Backstage (Custom Security Plugin) |
| Secrets | OCI Vault |
| Compliance | OCI Logging + OCI Audit Service |
| Compute | OCI Kubernetes Engine (OKE) |
- FDA Audit Prep Cut From 4 Weeks to Under 4 Hours: Scan results, SBOMs, rotation records, and pipeline logs auto-captured in OCI Audit - evidence package generation is a sub-4-hour export, not a 4-week engineering effort.
- Zero Unscanned Images Reaching OKE: Trivy and SAST on every build block critical/high CVE images before OCIR - no image deploys to OKE without a complete scan record.
- 100% SBOM Coverage Per Build: Every pipeline run generates an immutable SBOM in OCI Object Storage - full component traceability from source commit to production deployment, fully automated.
- Hard-Coded Secrets Eliminated: OCI Vault with Dagger enforcement eliminates all hard-coded secrets - tamper-proof rotation history logged to OCI Audit and available for immediate auditor review.
- Live Compliance Dashboard for the CISO: Custom Backstage plugin delivers RAG status, CVE counts, and DORA metrics for all 60+ services - refreshed every pipeline run, no spreadsheets required.
Client Testimonial
“We used to spend three weeks pulling evidence together every time an auditor asked a question. Now every build generates its own compliance record automatically – our audit preparation is a report export, not a fire drill.”
– CISO / VP Engineering.
Conclusion
A pharma enterprise running 60+ regulated OKE services with manual security scanning, 4-week FDA audit cycles, no SBOM generation, and hard-coded secrets was transformed into a continuous compliance operation through Ksolves DevSecOps consulting services. Dagger pipelines now embed five security stages into every build, FDA audit prep dropped from 4 weeks to under 4 hours, 100% SBOM coverage achieved, hard-coded secrets eliminated, and the CISO has a live compliance dashboard across all 60+ services. Every production deployment is traceable to its scan results, SBOM, and Git commit through OCI Audit by default.
