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Three case studies, each anonymized at the customer’s request. Industry, headcount, region, modules used, before-and-after metrics, and the implementation timeline. No vibes.

11 wk → 6 d

SOC 2 audit prep, before → after

47

contract obligations surfaced and now tracked

0

regulator findings on the latest NYDFS exam

Case 01 / 03 · Series B life-sciences SaaS

Life sciences software

Size: 120 employeesRegion: US + EUModules: GRC, Audit, Vendor Risk, Pen Test
The problem

Eleven-week SOC 2 audit prep. HIPAA evidence in three different SharePoint folders. The CISO and the Compliance Director kept finding out about each other’s work in the Slack #audit channel. Engineers had been asked to fill out the same vendor security questionnaire four times in two quarters.

The approach
  • 01Imported existing SOC 2 control library from a spreadsheet, mapped to HIPAA in 90 minutes via the cross-mapping engine.
  • 02Wired up GitHub, AWS, and Okta integrations on day one. 800+ pieces of evidence auto-collected within the first week.
  • 03Migrated vendor questionnaire history into the vendor module. Auto-populated incoming questionnaires from prior responses + public trust pages.
  • 04Set up continuous control testing for 36 SOC 2 controls. Failed tests now open Jira tickets directly to the owning team.
Cut SOC 2 audit prep from 11 weeks to 6 days. The auditor stopped asking us to ‘send the spreadsheet’ because there was no spreadsheet. The first time the auditor closed a control on their own, our compliance lead cried a little.
VP of Engineering·Series B life-sciences SaaS
Before / after
Audit prep time
Before
11 weeks
After
6 days
Evidence auto-collected
Before
12%
After
94%
Vendor onboarding cycle
Before
21 days
After
3 days
Engineer hours / quarter
Before
180 hrs
After
22 hrs
Implementation timeline
W0
Tenant provisioned. SOC 2 + HIPAA control libraries activated.
W1–2
GitHub, AWS, Okta integrations wired. First evidence auto-collected.
W3–4
Vendor library migrated. Continuous control testing live for 36 controls.
W6
First fully opsnite-led SOC 2 audit. Six business days of prep, zero deficiencies.
Outcome today

Audit prep went from a quarterly fire drill that pulled engineering off the roadmap to a continuous background process. The compliance team now spends time on programmatic improvements, not evidence hunts.

Case 02 / 03 · Mid-market clinical lab

Diagnostics / clinical operations

Size: 380 employeesRegion: USModules: GRC, Audit, Vendor Risk, Contracts
The problem

HIPAA + 21 CFR Part 11 + GxP across three lab sites. Quarterly validation audits, annual external audit, monthly internal audit. Lab inventory, vendor BAAs, and validation evidence (IQ/OQ/PQ) were maintained in three separate systems with no shared identifier. A single regulatory inspection meant six weeks of prep and three full-time people pulled off the floor.

The approach
  • 01Multi-framework GRC setup: HIPAA, HITRUST CSF, 21 CFR Part 11, and GxP mapped to a single 220-control library.
  • 02Vendor risk module loaded with 84 vendors. BAA + DPA tracking with renewal alerts. Auto-monitoring of public security signals.
  • 03Validation artifacts (IQ/OQ/PQ) ingested into the audit module. Searchable, retrievable, attached to specific controls.
  • 04Custom workflow: every validation event now opens a structured engagement; evidence collected in-flow; report generated at close.
HIPAA and 21 CFR Part 11 evidence collection went from a quarterly project to a continuous background process. When the FDA inspector showed up unannounced, we had everything ready in fifteen minutes. That used to take three days.
Director of Compliance·Mid-market clinical lab
Before / after
Pre-audit prep time
Before
6 weeks
After
4 days
Evidence retrieval (any item)
Before
~30 min
After
<2 min
Validation cycle time
Before
5 weeks
After
11 days
Quarterly fire-drill projects
Before
3 / qtr
After
0
Implementation timeline
W1–2
Multi-framework control library set up. 220 controls mapped across HIPAA / HITRUST / 21 CFR Part 11 / GxP.
W3–4
84 vendors imported. BAAs digitized. Continuous monitoring active.
W5–7
Validation artifact migration. 1,800+ IQ/OQ/PQ documents indexed.
W10
First annual external audit run end-to-end through opsnite. Zero observations.
Outcome today

The unannounced FDA visit closed without a single document request going unanswered. The CCO has since made opsnite the centerpiece of the lab’s accreditation strategy.

Case 03 / 03 · Late-stage fintech

Financial technology

Size: 950 employeesRegion: US + UKModules: GRC, Audit, Vendor Risk, Contracts
The problem

NYDFS 500, FFIEC, SEC marketing rule, GLBA, PCI-DSS. Vendor concentration risk was a known unknown. The vendor management team could not name the top five vendors by transaction volume without a one-week analysis. Contract obligations (audit rights, data residency, breach notification) lived in Word documents nobody read after signing. A regulator finding was overdue.

The approach
  • 01Stood up vendor risk with concentration views. Vendors ranked by transaction-flow exposure, not by spend. Surfaced fourth-party dependencies as nodes.
  • 02Migrated 312 contracts into the contracts module. Obligation extraction surfaced 47 active obligations no one was tracking.
  • 03NYDFS 500 + FFIEC control libraries activated. Mapped to existing internal control catalog.
  • 04Regulator-facing read-only audit workspace. Examiner gets scoped access; team avoids becoming a copy-paste service.
The vendor concentration view caught a fourth-party dependency that would have been a regulator finding. We saved it before it landed. Three weeks later when the NYDFS exam started, we had the auditor running queries themselves instead of asking us for things.
Chief Compliance Officer·Late-stage fintech
Before / after
Time to vendor concentration map
Before
~1 week
After
Real-time
Contract obligations tracked
Before
0
After
47 active
NYDFS exam evidence cycle
Before
3 weeks
After
4 days
Regulator findings (latest exam)
Before
7
After
0
Implementation timeline
W1–2
Vendor risk + concentration views. 312 contracts migrated.
W3–4
Obligation extraction surfaced 47 untracked commitments.
W5–6
NYDFS 500 + FFIEC control libraries activated and mapped.
W9
NYDFS exam: zero findings. Examiner used opsnite directly to pull evidence.
Outcome today

First NYDFS exam with opsnite closed clean. The vendor concentration map is now a standing item in the quarterly board risk review. Contract obligation breaches dropped to zero.

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