Compliance & Audit

Stay audit-ready without the busywork.Automate the documentation your team does by hand.

Your compliance and quality teams are meticulous — that's why you pass inspections. But they're spending too much time assembling documentation, chasing training records, and manually maintaining audit trails. We automate the paperwork so your team can focus on actual compliance, not compliance busywork.

Always

audit-ready

Real-time compliance dashboard

Auto

generated SOPs

From workflow configurations

100%

complete audit trails

Every action, every system

We study your compliance workflow

We sit with your quality and compliance teams. We map how documentation is created, maintained, and retrieved. Where are the manual steps? Where do things fall through the cracks?

We automate the documentation

Not the compliance decisions — those require human judgment. We automate the manual steps around documentation: QC records, audit trails, training logs, SOP generation. Custom-built for your regulatory requirements. AI auto-generates SOPs from your workflow configurations and flags compliance gaps. Audit trail logging is deterministic — no AI needed. Right tool for each requirement.

Your team stays focused on compliance

Same team, same standards. But they spend their time on actual compliance work — reviewing, deciding, improving — instead of assembling paperwork and chasing signatures.

💡

"My quality system already does some of this."

It probably does. We don't duplicate what works. We find the gaps — the manual steps your quality system doesn't cover — and automate those. Every organization's gaps are different. That's why we start with an assessment, not a demo.

Problems We've Solved

Common Compliance & Audit bottlenecks we automate

Every operation is different. We work with you to identify the ones that cost you the most.

01
Manual QC Docs
QC documentation assembled manually from instrument data
Today
Transcribing QC data
Techs record results on paper, enter them into the QC system. Time-consuming and error-prone.
What we build
Auto QC capture
Instrument data flows directly into your QC system. Out-of-range results trigger corrective action workflows.
Your team
Always current QC
QC records are always complete and traceable back to the instrument output.
02
Audit Trail Gaps
Steps between systems have no trail at all
Today
Gaps between systems
LIMS and EHR have trails, but data transfers and workarounds have none.
What we build
Unified audit trail
Every action across every connected system logged in one immutable, searchable record.
Your team
Answers in seconds
Compliance team answers any audit question instantly. No reconstructing timelines.
03
Scattered Training
Training records in binders, shared drives, and email
Today
Binder archaeology
Records scattered across LMS, shared drives, and email. Inspector asks for proof — team scrambles.
What we build
Centralized training
Records linked to specific SOPs and versions. Permissions gated by training status.
Your team
Instant verification
Every person's training status visible instantly. Inspectors get answers in seconds.
04
Manual SOP Updates
SOP updates done by hand every time a process changes
Today
Weeks-long SOP cycle
Update doc, route for review, get approval, distribute, confirm read. Falls behind reality.
What we build
AI-generated SOPs
SOPs auto-generated from workflow configs. Review, approval, and distribution automated.
Your team
SOPs match reality
Always reflect current practice. Version control is automatic.
05
Inspection Panic
Inspection prep takes weeks of document assembly
Today
Binder assembly
Compliance drops everything to pull QC records, training logs, and reports from multiple systems.
What we build
Compliance dashboard
Real-time status for every required document. Pre-built inspection packages on demand.
Your team
Always ready
No inspection panic. Documentation is always organized and current.
06
07
08
Don't see yours?
Every operation has its own. We find the ones that cost you the most.
Step 1
You tell us
Where your team spends the most time on manual work.
Step 2
We map the workflow
And identify the automation opportunity with ROI.
Step 3
First workflow live
Working automation in your environment within 60 days.
Schedule a workflow exploration call

With an engineer — not a salesperson. No commitment.

Real Results

How a pathology network achieved always-on compliance

A multi-site pathology network was managing compliance across multiple CLIA-regulated laboratories. Their quality team was experienced and thorough, but the sheer volume of documentation — QC records, training logs, equipment maintenance, proficiency testing — across multiple sites made it nearly impossible to stay current without dedicating the entire team to paperwork.

We built a unified compliance automation layer across all their sites. QC documentation was auto-generated from instrument data. Training records were centralized and linked to SOPs. Audit trails were unified across their LIMS, EHR, and document management system. A real-time compliance dashboard gave the quality team instant visibility into every site's status.

The quality team didn't change — they were already excellent at maintaining standards. What changed was how much manual assembly stood between them and compliance. Inspection prep went from weeks to minutes. Documentation gaps were caught in real time instead of during pre-inspection scrambles. The team finally had time to focus on quality improvement instead of quality documentation.

Read the full case study

100%

audit trail coverage

Minutes

inspection prep time

Auto

QC documentation

Zero

compliance gaps

How We Work

What a typical engagement looks like

No two engagements are the same — because no two compliance environments are the same. But this is the general shape.

1–2 weeks

Assess

We sit with your quality and compliance teams. We map your regulatory requirements, your documentation workflows, and your current gaps. We identify the manual steps that create the most risk and consume the most time. We tell you exactly what we'd automate.

Free workflow exploration + $1,999 deep roadmap

4–12 weeks

Build

We build the compliance automation — audit trails, QC documentation, training management, SOP generation — on top of your existing systems. Everything is validated and documented to meet your specific regulatory requirements. Go live in phases.

$25K–$75K depending on scope

Ongoing

Run

We monitor compliance status, maintain integrations, and update automation when regulations change. When a new CAP checklist comes out or FDA guidance updates, we adapt. Your team focuses on compliance decisions — we handle the documentation infrastructure.

$2K–$5K/month · 30-day cancel anytime

As needed

Expand

Most clients start with audit trails or QC automation. Once that's running, we tackle training records, SOP management, or inspection dashboards. Same approach, same team, progressively more coverage.

Scoped per project

$50K Savings Guarantee

If we can't identify $50K in annual savings during the Roadmap phase, we refund the $1,999. You keep the analysis either way.

We Work With Your Stack

We don't replace your systems. We connect them.

We've built integrations with these systems — but if yours isn't listed, we'll figure it out. That's the job.

Orchard LIMSSunquestCerner PathNetEpic BeakerMasterControlQualioGreenlight GuruSAP QMVeeva VaultTrackWiseSharePointConfluence

Common Questions

Before you book

Let's simplify your compliance documentation.

Schedule a workflow exploration call with an engineer — not a salesperson. We'll map your compliance workflow, find the manual documentation steps that consume the most time, and tell you exactly what we'd automate. Free, no obligation.

Book Free Assessment

Or call us: 1-877-326-1761