Candor · by Red Hen Admin
Your internal audit program, run for you.
Candor is the platform behind Red Hen Admin’s managed internal-audit service for medical device manufacturers. We run your audits on a real schedule, track every finding to closure, and keep your quality system audit-ready all year — so an FDA inspection or notified-body visit is a Tuesday, not a fire drill.
Everything in one place
One home for every audit and inspection
Internal audits, supplier audits, FDA inspections, notified-body visits, certification audits — every audit and inspection your company touches, tracked in one place. No more findings languishing unchecked in a file folder on a network drive, scattered across five different folders on five different drives, or living only in the head of whoever ran the audit last.
Candor is the single, current record of where every finding stands — open, in progress, verified, closed — so nothing slips, and you can prove it.
What it is
An internal-audit program and the system that keeps it honest
Most small manufacturers know they’re supposed to audit themselves — ISO 13485 §8.2.2 and the FDA QMSR require it — but a team of two can’t credibly grade its own homework, and audits done in a hurry the week before a certification visit don’t catch anything.
Candor solves both halves. Red Hen Admin provides the independent auditor; Candor provides the system of record — the schedule, the findings, the corrective actions, the compliance health score, and the management-review inputs — so the whole program is real, traceable, and ready when a regulator asks to see it.
It’s the difference between “we have a procedure” and being able to show your work, all year long.
Audit vs. Overwatch
A one-time audit gives you an objective snapshot. Perfect before a certification push or when you need an independent read.
Candor is the ongoing program — quarterly audits, continuous tracking, and a living record of your quality system’s health.
How it benefits you
What you actually get
Audit-ready all year
Quarterly internal audits on a documented audit schedule. No December scramble, no surprises when an inspector arrives.
Findings & Audit CAPA tracking
Every finding tied to a requirement and tracked to closure — with effectiveness verification, not just “we updated the SOP.”
Compliance health score
A clear, at-a-glance read on where your quality system stands — and where it’s drifting — before it becomes a finding.
Trends & objectives
See what your findings are telling you over time, and track your own quality objectives alongside them. Included on every plan.
Management-review inputs
Audit results, trends, objectives, and your organizational change log roll straight into a management-review pack — instead of dying in a binder.
An independent set of eyes
A BSI-certified lead auditor runs your program — the independence ISO 13485 expects, which an internal team of two can’t provide on its own.
Audit schedule & coverage
Every requirement on a documented schedule — see when each clause was last audited and when it’s next due. Printable proof of full coverage for your registrar.
Built for confidential, regulated data
Security worthy of your quality records
Your audit findings, evidence, and signed reports are some of the most sensitive records you keep — and under the QMSR, FDA can read them. Candor treats them that way.
Multi-factor authentication
Every account is protected with app-based MFA and re-verification for sensitive actions. Role-based access means each client sees only their own data — nobody else’s.
Secure document & evidence storage
Audit evidence, procedures, and reports live in encrypted, access-controlled storage — not an email thread or a shared drive anyone can wander into.
Electronic signatures
Audit reports are locked and electronically signed, with a clear record of who signed what and when — a defensible, tamper-evident trail for every report.
Backed by a mutual confidentiality agreement, an append-only acceptance log, and automatic session timeouts — so your most sensitive records stay confidential, traceable, and yours.
How much it costs
Simple, annual plans
Every plan includes onboarding, quarterly internal audits, findings & audit CAPA tracking, compliance health, trends, objectives, and management-review inputs. Pay annually or monthly (annual saves a month).
Essentials
$5,489/yr
or $499/month
Quarterly remote/desktop audits
Single site · up to 3 portal users
4 quick audits / year
3-business-day response
Standard · most popular
$9,339/yr
or $849/month
Quarterly: 1 on-site + 3 remote
Up to 2 sites · up to 5 portal users
6 quick audits / year
2-business-day response · quarterly check-in
Partner
$16,489/yr
or $1,499/month
Quarterly: 2 on-site + 2 remote
3+ sites · unlimited portal users
8 quick audits / year
1-business-day response · monthly check-in
One-time
Comprehensive Internal Audit — $7,999
A full, on-site internal audit with a signed report. No subscription — perfect before a certification push or when you just need an independent read.
Single site · up to three on-site days · Southern California only.
Add-on
Supplier Audits — $1,500 / on-site day
Second-party supplier qualification and monitoring audits, on your procedures and forms. Available to any plan.
On-site audit days include travel within California. For on-site audits outside California, reasonable travel and lodging expenses are billed at cost and agreed in advance.
Get started
Let’s make audit season boring
Start your program online, or talk it through with us first — we’ll help you pick the right plan and map your first baseline audit.