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Helios Bio

4× faster compliance audit cycle in life sciences

Life Sciences 2,800 employees Compliance HIPAA
faster audit cycle
214
HIPAA findings resolved
17d
vs. prior 11-week cycle
0
audit exceptions
Company
Helios Bio is a clinical-stage biopharmaceutical company developing precision therapies for rare metabolic disorders. Founded in 2016, headquartered in San Diego, CA.
Environment
  • Salesforce Health Cloud + Sales Cloud
  • 31,400 custom fields across 180 objects
  • HIPAA-regulated data environment
  • Annual SOC 2 Type II audit requirement
Challenge

Helios Bio operates under dual audit pressure: HIPAA compliance reviewed annually by external auditors, and SOC 2 Type II certification renewed every 18 months. Both require documented evidence that every field containing or adjacent to protected health information (PHI) is described, governed, and access-controlled.

The 2024 audit cycle took 11 weeks of admin and compliance team time to complete. Two weeks before the 2025 audit window opened, the lead Salesforce admin estimated they were 40% ready — with 18,800 fields lacking compliant help text and 214 fields flagged as HIPAA-adjacent with outdated or missing access documentation.

“The prior audit consumed 11 weeks of our team's time. With OrgLens, we closed the 2025 cycle in 17 days and had documentation that was materially better. Our auditors asked who wrote it.”
— Director of IT Compliance, Helios Bio
Solution

Helios connected OrgLens with the HIPAA compliance pack enabled. The initial scan catalogued 31,400 fields in 4h 40m and returned a prioritized findings queue sorted by compliance risk. The 214 HIPAA-adjacent fields with unresolved access documentation appeared at the top of the queue, pre-triaged with specific risk categories: PHI-adjacent (87 fields), deprecated access controls (71 fields), undocumented data flow (56 fields).

Three admins worked the review queue in parallel using object-based sprints. The HIPAA compliance pack's redaction engine suppressed PHI from model inputs and flagged 12 fields with active PHI in their labels — findings that were escalated immediately to the compliance team. All 214 priority findings were resolved in 9 business days. The remaining documentation backlog — 18,800 fields — took 8 additional days.

Deployment timeline
Day 1
Org connected, HIPAA pack enabled
Initial scan complete in 4h 40m. 214 priority findings surfaced. Team briefed on review workflow.
Days 2–9
Priority findings resolved
All 214 HIPAA-adjacent findings resolved. 12 PHI-in-label findings escalated and remediated. Access documentation updated for 71 deprecated controls.
Days 10–17
Full documentation backlog cleared
18,800 previously undocumented fields reviewed and approved. Audit package exported from OrgLens trust center.
Day 17
Audit complete — zero exceptions
External auditors completed field documentation review. Zero exceptions. Helios retained OrgLens Enterprise for continuous governance.
Outcome

The 2025 compliance audit completed in 17 days — a 4× reduction in cycle time compared to the 11-week 2024 cycle. Zero documentation exceptions were returned by the external auditors. The compliance team estimated 340 hours of manual documentation work displaced by OrgLens across the two-week engagement.

Helios retained OrgLens on the Enterprise plan for continuous governance. Their deployment workflow now requires documentation approval before any new field is promoted to production — implemented as a checkpoint in their Salesforce DX pipeline.

“We used to dread the compliance audit window. Now we walk into it with a complete audit package generated by the tool. The auditors reviewed the OrgLens trust center export before they reviewed a single record. That's a fundamentally different conversation.”
— Salesforce Practice Lead, Helios Bio
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