Built for 503B outsourcing facilities

Before the lot ships.
Not after.

Six FDA checks run before anyone signs off. Each one cites the exact regulation it's enforcing. The full record is permanent from the moment it runs.

Request a Demo 30 minutes  ·  No setup required
BLOCKED P1 · 211.192
BLOCKED P2 · 211.42
BLOCKED P3 · 211.167
FLAG P6 · 211.113(b)
PASS P4 · 211.68

Every batch release means checking
five different systems against five different regulations.

When one person has to cross-reference all of that manually, something eventually gets missed.

LIMS Lab results — sterility, endotoxin, potency 211.165 · 211.167
QMS Open deviations and investigations 211.192
EM Environmental monitoring results 211.42(c)(10)(iv)
CMMS Equipment qualification records 211.67 · 211.68
LMS Operator qualifications and media fill history 211.113(b)

In 2025, FDA issued a Warning Letter to a 503B facility for releasing a sterile injectable despite three open cGMP violations across three of these systems. The lot was recalled.

FDA Warning Letter · 2025 · Sterile injectable · Recalled

How it works.

1
Submit
Enter the lot details — area, equipment, operators — and submit for review.
2
Check
Archon queries your LIMS, QMS, EM system, CMMS, and LMS. All six rules run at once.
3
Verdict
PASS, FLAG, or BLOCKED — with the exact CFR citation for each check.
4
Permanent Record
Everything goes into the audit log at the moment it runs. Nothing can be changed after the fact.
The Product

Six rules. One response.
Under two seconds.

Not a summary. The actual regulation — to the paragraph.

Batch Release Evaluation LOT-2024-0083 · Suite B ISO 5
2.1s
● BLOCKED
P1: Investigation Gate 21 CFR 211.192
Open deviation linked to this lot and manufacturing area. Per 21 CFR 211.192, batch release is not permitted until all discrepancies are formally investigated and closed.
Required: investigation formally closed and documented.
● BLOCKED
P2: EM Excursion Gate 21 CFR 211.42(c)(10)(iv)
Viable air sample: 3 CFU/m³ · Action limit (USP <1116>): 1 CFU/m³. Action limit exceeded by a factor of 3. Excursion investigation and product impact assessment required before release.
Required: root cause investigation complete, product impact assessment documented.
● BLOCKED
P3: Sterility & Endotoxin Gate 21 CFR 211.165, 211.167
Sterility test (USP <71>) status: PENDING — Day 7 of required 14-day incubation. Per 21 CFR 211.167, sterile products may not be released until sterility testing is complete.
Required: sterility test complete with result recorded as PASS.
◐ FLAG
P6: Operator Qualification Gate 21 CFR 211.113(b)
Operator media fill qualification expires in 7 days. Qualification is currently valid; however, renewal is within the 30-day alert threshold. QA Supervisor review required to proceed.
Recommended: schedule media fill renewal immediately.
✓ PASS
P4: Equipment Qualification Gate 21 CFR 211.68
All production equipment within active qualification period at time of manufacture. Isolator, autoclave, and filling line: current.
Each verdict is permanent. Written to the audit log at the moment it's issued — nothing changes after.
Regulatory Coverage

Encoded from the regulation.
Not interpreted from it.

Each rule enforces a specific paragraph. The same batch checked twice gets the same answer.

P1
BLOCKED
Investigation Gate
21 CFR 211.192
No batch may be released when an open investigation is linked to the lot, manufacturing area, or production equipment.
P2
BLOCKED
EM Excursion Gate
21 CFR 211.42(c)(10)(iv)
Environmental monitoring action limits (per USP <1116>) must not be exceeded in the production area during the manufacturing window.
P3
BLOCKED
Sterility & Endotoxin Gate
21 CFR 211.165, 211.167
Required laboratory tests — including the full 14-day sterility incubation per USP <71> — must be complete and passing before release.
P4
BLOCKED
Equipment Qualification Gate
21 CFR 211.67, 211.68
All production equipment must be within its active qualification period at the time of manufacture, not at the time of release.
P5
PASS
Change Control Gate
21 CFR 211.100(a)
Change control documentation must be complete for any process changes affecting the batch. Enforced upon QMS integration.
P6
FLAG
Operator Qualification Gate
21 CFR 211.113(b)
All operators who accessed the ISO 5 environment must hold a current media fill qualification at the time of manufacture.

The FDA sets the floor.
Your SOPs set your standards.
Archon enforces both.

We ingest your existing documents — whatever format they're in, wherever they live. No extra work on your end. Your QA Director reviews what we found and decides what gets enforced.

01
We ingest your documents
PDFs, Word docs, SharePoint, network drives — wherever your SOPs already live. We handle the ingestion. You don't move anything.
02
Archon extracts the requirements
Who needs to approve what. What evidence is required. Which roles are restricted. Pulled from your procedures automatically.
03
Your QA Director approves
We show you what we found. You decide what gets enforced. Nothing activates without a human sign-off — and that approval is on the permanent record.
TIER 2 FLAG Final batch disposition requires QA Director sign-off  · SOP-QC-007 §4.2.1

When FDA comes in, every decision is already documented.

What ran. What it found. Who reviewed it. When.

→
Same batch, same answer
The same lot checked twice gets the same verdict both times. No variance by user, by session, or by time of day. If an auditor asks why something was blocked 18 months ago, the answer hasn't changed.
#
The actual regulation, not a summary
A blocked sterility result doesn't just say "testing incomplete." It cites 21 CFR 211.167 — the actual paragraph. That's what's in the log and that's what FDA is looking at.
|
Nothing changes after the fact
Verdicts, overrides, and every action in the system get written to a permanent log the moment they happen. No one can go back and change them — including us. That's what makes it useful in an inspection.
Proactive Monitoring

Most compliance gaps don't happen
at batch release.

They build up quietly. A license that slipped. An investigation window that closed. Archon keeps watching so you don't have to.

Lapsed State Licenses
Immediate unlawful shipment exposure. Detected with renewal instructions and fees.
Expiring State Licenses
Surfaced before lapse with configurable lead times, fees, and renewal steps.
Overdue Investigations
48-hour initiation window tracked per event. Hours overdue surfaced immediately.
Expired Authorizations
Batch authorizations past their end dates and not formally closed.
Incomplete Pre-Release Checks
Required verifications marked needed but not recorded as complete.
Compliance Findings
LAPSED
State License — Texas
License expired 3 days ago. Suspend TX shipments immediately. Initiate emergency renewal. Annual fee: $1,400.
EXPIRING
State License — Florida
License expires in 12 days. Initiate renewal immediately. Annual fee: $850.
OVERDUE
Investigation Required — ANO-2024-0156
Event occurred 51 hours ago. 48-hour investigation initiation window has elapsed. Formal investigation required now.
AI Remediation Agent

Blocked. Your team gets
the full picture immediately.

The moment a lot is blocked, your QA team receives a step-by-step plan. What's wrong, which regulation, and exactly what needs to happen — before anyone has to ask.

A
Archon Compliance Agent
just now
⛔ LOT-2024-0083 blocked — 3 issues require resolution before release
P1 — Open investigation (21 CFR 211.192)
1.Assign an investigation lead to the open deviation record immediately.
2.Complete root cause with documented findings.
3.Close the record in QMS before the next release attempt.
+ 2 more violations  ·  P2 (EM exceedance)  ·  P3 (sterility pending)
Archon Compliance Agent · 21 CFR 210/211 · Sent to QA team

Designed for 503B.
Meets 21 CFR Part 11 requirements.

§
21 CFR Part 11 Designed
Audit trails, access controls, and record integrity meeting FDA electronic records requirements.
⊗
Immutable Audit Log
Append-only, enforced at the database layer. No record is ever modified after creation.
⊕
Role-Based Access Control
Enforced server-side. Cannot be bypassed through the interface.
≡
Deterministic Evaluation
Same inputs, same verdict, every time. No inference, no probabilistic output.
◎
SOC 2 Type II — In Progress
Security controls, availability, and confidentiality assessment underway.
⊙
DQSA Section 503B
Built specifically for the regulatory requirements of outsourcing facilities under DQSA.

See it run on your products,
your area, your procedures.

We'll walk through a live session built around your facility — your lot types, your manufacturing areas, your SOPs.

Request a Demo 30 minutes. We handle the setup.