GxP · 21 CFR Part 11 · ALCOA+

Your lab software, untouched.
Your compliance, absolute.

Compliance ARMOR wraps unmodified Windows instrument software in a tamper-evident audit layer — hash-chained records, electronic signatures, and a plain-English story of everything that happened. No rewrites. No replacement projects.

SHA-256 hash chainEd25519 e-signatures Zero code changes608 automated tests
Compliance ARMOR — Audit Console — ▢ ✕
LIVE Chain verified ⛓ 9f3a…c21e
Launch locked
Signature sealed
Capture scoped

Why it exists

Replacing validated lab software is a multi-year project. Wrapping it isn't.

Your instruments run software that was validated once and must not change. ARMOR sits around it — watching, sealing, and proving — so you get a modern Part 11 audit trail without touching the application your lab depends on.

Watch

The agent supervises the unmodified application — every launch, file, signature and screen — from outside, with no code changes.

Seal

Each event is written to a hash-chained, HMAC-signed ledger and timestamped by an external authority. Tampering becomes mathematically obvious.

Prove

A plain-English trail and one-click signed exports turn "trust us" into evidence an inspector can verify independently.

What it does

Five things it does at the bench — every time.

Real behaviours of the system, exactly as they run on the instrument PC.

Launch Lock

The instrument application can only be opened through ARMOR, so no work ever happens off the record.

Audit Trail

A hash-chained record of every action, rendered in plain English — not raw system noise.

Tamper Test

Change one byte of a sealed record and the chain breaks visibly. Integrity you can prove, not promise.

E-Signature

Ed25519 electronic signatures bound to the record and the signer, with a mandatory reason.

Session Trail

Every run reconstructed as a readable story — who, what, when, on which instrument.

Scoped Capture

Evidence snapshots of the instrument window only — never the whole desktop. Privacy by design.

Watch it work — live

Don't read about it. Watch it happen.

Five real behaviours of the system, animated as they run at the bench. One of them you get to break yourself.

Launch Lock — LAB-WS-04— ▢ ✕
1

Someone double-clicks the EXE

Straight on the desktop, bypassing everything.

2

Windows itself says no

An ACL deny rule means the program physically cannot start outside ARMOR.

3

Launch through ARMOR instead

The operator authenticates — a real, accountable person.

4

Unlocked & supervised

Every action from this second is on the record.

PhenomImageViewer.exe
double-click on the desktop…
Access denied
ACL launch lock — start via Compliance ARMOR
Identity verified
a.mueller · authenticated
Supervised · REC
session #4471 · every action on the record
Audit Trail — everyone, everything, in orderSTREAMING

Six sealed events. Go ahead — edit one directly, like an attacker with database access would. See how long it survives.

Chain broken. Hash mismatch at event #3 — every event after it is now unverifiable. Tampering detected in 0.3 s.
#1
a.mueller

launched PhenomImageViewer

⛓ 7c2e…a914
#2
a.mueller

opened sample_0447.tiff

⛓ a914…f37b
#3
a.mueller

saved result — 12.4 µm

⛓ f37b…08d2
#4
j.weber

reviewed record

⛓ 08d2…4be1
#5
s.fischer

approved & e-signed

⛓ 4be1…d90c
#6
system

chain anchor sealed

⛓ d90c…22af
Electronic Signature — result_0447.tiff— ▢ ✕
1

A record awaits approval

result_0447.tiff is reviewed — now it needs a signature that means something.

2

The signer states their intent

Meaning and reason are mandatory — §11.50 demands it.

3

Password unlocks a private key

Each user owns an Ed25519 key only their password can open.

4

Sealed into the chain

Anchored to the audit chain — it can never be moved, copied, or detached.

result_0447.tiff
reviewed · awaiting approval
Meaning: Approved
reason: "results within spec — release"
Key unlocked
Ed25519 · s.fischer · •••••••••
Signature sealed
⛓ anchored to event #5 · immutable
Session Trail — run #4471, reconstructed— ▢ ✕
09:41:02 · MBG-LAB-01

Session started by a.mueller

PhenomImageViewer, supervised
09:41:18

Opened sample_0447.tiff

original sealed to vault
09:43:55

Saved result — 12.4 µm

screenshot captured
10:02:11

Reviewed by j.weber, approved & e-signed by s.fischer

reason recorded
10:02:12

Session closed · chain anchored

every step above, provable

Built to be trusted

Engineered like the records it protects.

0
Automated tests, green
SHA-256
Hash-chained ledger
Ed25519
Electronic signatures
RFC 3161
External timestamping

Questions

Asked by every lab. Answered here.

Does Compliance ARMOR modify our instrument software?

No — that's the entire point. Your vendor software runs exactly as shipped, byte for byte. ARMOR supervises it from the outside: controlling how it launches and recording what happens around it. Your existing validation of the instrument software stands.

What software does it work with?

Any Windows application. ARMOR uses a tiered model: generic capture (process lifecycle, windows, watched-folder file events, clipboard, signatures) works with everything out of the box, and deep per-application adapters can be added for the instruments that matter most.

Where does our data live?

On your infrastructure. The backend is a self-hosted FastAPI + PostgreSQL stack — deploy it on a lab server, in your data center, or in your private cloud. Nothing leaves your control.

How do you prove records weren't tampered with?

Every audit event includes a cryptographic hash of the previous event, forming an unbroken chain. Change anything — even one character, even in the database directly — and verification fails from that point forward. Signatures add a second, per-user cryptographic layer on top. Try it yourself in the Tamper Test.

What about validation documentation?

ARMOR ships with test protocols, execution logs, a traceability matrix, and a documented compliance posture — a running start for your CSV package instead of a blank page.

See your own instrument, wrapped and sealed.

A live walkthrough on your software, with your compliance team in the room. No install, no commitment.