VGN-WEB-001 | Rev 4 | Effective 2026-09-15 | Classification: Public (pending reclassification) | Documents generated this session: 000
Pre-release — pending release-date approval

Because software was getting shipped far too easily.

VOGON is the AI agent that maintains the GxP evidence trail around software development — requirements, risk, traceability, verification, and change control — continuously, from the systems your engineers already use.

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No credit card required. A signed statement of intent is required.

The VOGON compliance officer VOGON // Controlled copy · Ref VGN-CR-001 · Rev 0
Deployed at
Biologics Therapeutics Pharma Life Sciences Diagnostics

Client names withheld pending completion of the reference-approval process (Form VGN-REF-004). Estimated completion: 2029.

§ 1.0 Why VOGON

The problem is well understood.

Modern GxP software development requires rigorous traceability between requirements, risks, implementation, verification, and change control.

Unfortunately, it also requires developers.

Developers produce working software, which is helpful, and then decline to produce the documentation proving that they produced it, which is a finding. VOGON resolves this tension by generating the documentation regardless of developer cooperation, enthusiasm, or continued employment.

“Turn your development velocity into regulatory evidence.”

A VOGON compliance officer reads a requirements document aloud to a developer holding their head in their hands
§ 2.0 Platform

Derived, then enforced.

VOGON sits between the tools engineers use and the quality system auditors read. It derives the regulated record from what actually happened in the repository and the pipeline, then renders the parts a regulator asks for.

A developer clutching their head in front of a submission stamped REJECTED, listing insufficient traceability, missing risk assessment, incomplete validation evidence and requirements not met, beside towering stacks of SOPs and audit findings

A ticket becomes a requirement with an identifier. The requirement gets a risk score. A pull request claims the requirement, and VOGON checks the claim against the diff, the tests that ran, and the reviews that happened. Complete links pass the gate. Incomplete links fail it, with the missing artefact named.

A passing review looks the same, minus the stamp, plus a link to the updated traceability matrix. Deficiencies are reported individually, so that each may be remediated, documented, and re-submitted individually.

Correct the named deficiency. Attach the evidence. Re-request review. The gate re-evaluates against the same criteria, plus any criteria introduced since your last submission.

Median time from first submission to merge is eleven days. The code change is typically finished on day one.

✓

Evidence is collected, not authored

Records derive from timestamped, attributable source systems. Nobody retypes a commit message into a Word template at 11pm.

✓

Continuous, not retrospective

The package is regenerable at any commit, so readiness is a property of the repository rather than a three-week panic before an inspection.

✓

ALCOA+ by construction

Attributable, legible, contemporaneous, original and accurate — because the record is generated from systems that already are.

✓

Risk-based, per CSA

Effort concentrates on high-risk, patient-impacting functionality instead of spreading uniformly across a login form.

✓

Humans approve

VOGON drafts, links and checks. Signatures remain human, and remain the point.

✓

Your QMS stays your QMS

Records are filed into Veeva, MasterControl or SharePoint as controlled documents. VOGON does not ask to become the system of record.

§ 3.0 Testimonials

Statements on file.

“I used to hate compliance. Now I hate myself.”
Senior Software EngineerSix months post-deployment · Verbatim, reproduced with permission of their employer
“Amazing. We deployed VOGON and half the developers rage-quit within a week. Our compliance metrics have never looked better.”
Senior Compliance OfficerTop-20 pharmaceutical manufacturer
“Our audit findings are down 73%. Developer morale is also down 73%. We believe this demonstrates excellent traceability.”
Head of ValidationContract manufacturing organisation
“This is a success story we’ll never talk about again. Ever.”
Executive SponsorEnterprise transformation programme
“I asked VOGON why my pull request needed seventeen supporting documents. It generated an eighteenth document explaining why.”
Staff Engineer
“Finally, an AI that understands the true purpose of software development: producing evidence that software development occurred.”
GxP Consultant
“Before VOGON, developers constantly argued with our processes. Now they just stare silently at their monitors.”
Director of Quality
“VOGON caught a missing signature from 2019. Nobody knows whose signature it was supposed to be. The investigation remains ongoing.”
Quality Systems Manager
“VOGON reduced our average change-request discussion from three hours to zero. It simply rejects them.”
QA Manager
“Training completion is at 100%. Nobody remembers taking the training.”
Head of Quality Training
“My change request was rejected because the justification for the change request did not sufficiently justify submitting a change request.”
Developer
“We wanted to automate compliance. Technically, we succeeded.”
VP of Engineering
“10/10. Would not submit again.”
Developer

Statements are retained for fifteen years and may not be withdrawn by the individual who made them. Additional references available on request, subject to Form VGN-REF-004 and the reference-approval process.

§ 4.0 Safety information

Known side effects.

Reported by users during the pre-release programme. This list is not exhaustive and is itself under revision.

VOGON — Prescribing information VGN-SAF-001 · Rev 9

Adverse effects

  • Anxiety
  • Depression
  • Loss of motivation
  • Acute documentation fatigue
  • Chronic requirements aversion
  • Sudden distrust of Jira
  • Compulsive traceability
  • Recurring audit nightmares
  • Unexplained production of Excel spreadsheets
  • Inability to merge without written approval
  • Spontaneous use of the phrase “per SOP”
  • Existential uncertainty about whether the software ever actually needed to exist
  • Rage quitting
  • Instant decapitation
  • Death by change-control board
  • Becoming a compliance officer

Rare effects

In rare cases, developers exposed to VOGON for more than six months have reported enjoying validation activities. If this occurs, discontinue use immediately and seek professional help.

WARNING
Do not operate VOGON while happy, creative, or attempting to ship software. VOGON has not been evaluated for use in healthy engineering organisations.
VOGON procedure VGN-PROC-001, the eleven-step issue submission process flowchart
§ 5.0 Support

Reporting an issue.

VOGON does not accept GitHub Issues. Defects and feature requests are submitted on paper, in triplicate, under procedure VGN-PROC-001.

  1. Print Form VGN-ISS-001 — Preliminary Notice of Intent to Report an Issue in triplicate.
  2. Complete all three copies by hand, in blue or black ink. Typed submissions are rejected.
  3. Obtain five signatures: requestor, requestor’s manager, Quality Assurance, system owner, independent witness.
  4. Submit each copy separately — original by registered mail, quality copy by fax, controlled copy retained in a fire-resistant cabinet for fifteen years.
  5. Allow 30–45 business days for acknowledgement. Acknowledgement does not constitute acceptance.

Issues opened directly through GitHub are closed with: REJECTED — Electronic submission received without corresponding paper record.

VGN-PROC-001 § 9.4 — Expedited handling

For urgent production incidents, follow the same process and write URGENT in the upper-right corner of all three copies.

Processing times are unaffected.

§ 6.0 Compliance

Held to every applicable standard.

VOGON is maintained under document control and assessed against the standards our customers are inspected against. The current position on each is recorded below.

Applicable standards
21 CFR Part 11Not certified EU Annex 11Not certified GAMP 5Category not assigned ISO 13485Scope under review IEC 62304Not assessed SOC 2Type I not commenced

Register maintained under VGN-STD-001, Rev 3. Applicability is not conformance. No certification, assessment, or audit against any listed standard has been performed, commenced, scheduled, or budgeted.

A VOGON executive presenting from a lectern to a conference audience that has fallen asleep, beside a slide headed Today's Agenda version 3.7
§ 7.0 Speaking

Bring VOGON to your next event.

Keynotes, panels, workshops and fireside chats, delivered to schedule and to slide count.

Topics include Turning InnovatioN into DocumentatioN, The Beauty of Bureaucracy, Why “Good Enough” Is Not Compliant, and Lessons from 42 Years of Process. Custom compliance content available upon approval.

Engaging audiences worldwide, one slide at a time. Bookings require an approved change request.

§ 9.0 Frequently asked questions

Questions, and the answers to them.

Is VOGON GxP compliant?
No.Ref: VGN-DIS-001, §2
Can VOGON validate my software?
VOGON can generate documents asserting that someone should validate your software.
Does VOGON replace our Quality team?
Yes. AI will replace all of us.Ref: VGN-HR-001 · Organisational efficiency plan, Rev 1
Can I disable change control?
Your request to disable change control has been submitted through change control.Ref: CR-0042 · Status: In review since 2024
Why was my change rejected?
Insufficient justification. Please submit a change request requesting clarification.
Can VOGON run in a validated environment?
VOGON has no validated state. Placing VOGON in your validated state is not supported and would itself constitute a deviation.
How long does the traceability matrix take to generate?
Less time than the meeting about why it was out of date.
What happens if VOGON is wrong?
A CAPA is opened. If the CAPA is wrong, a CAPA is opened.
Can we customise the document templates?
Yes, subject to template change control. Template change control is a template.
Do you offer a free trial?
A 30-day evaluation is available following completion of the evaluation-authorisation process, which takes 30–45 business days.
A VOGON officer seated in a restroom stall unspooling a continuous roll printed with a change request, requirements document, risk assessment and validation plan, beneath signs reading Same Crap Different Format and Wipe Away Compliance Pain
Every format your quality system accepts Figure 2 — Output formats · VGN-FMT-001 · Rev 5

The same linked record, rendered as whatever your eDMS, your auditor, and your 2011 validation SOP each insist upon. Same content. Different format.

Rendering targets Supported as of Rev 5

PDF/A-2b — archival submission copy, with embedded signature manifest.

Word (.docx) — for quality teams who will reformat it anyway.

CSV — traceability matrix, one row per requirement-to-evidence link.

Signed JSON — machine-readable manifest of the whole package, hashed per artefact.

Paper — printed, hole-punched, and couriered. Surcharge applies.

§ 10.0 Release status

VOGON is coming soon.

Release date pending successful completion of the release-date approval process.

Release gateStatus
Development completeApproved
Testing completeApproved
Validation completeApproved
QA reviewApproved
Release approvalApproved
Approval of release approvalIn review
Final sign-offREJECTED

Estimated availability is not a commitment and must not be interpreted as an approved implementation date.

A VOGON executive seated behind a Coming Soon nameplate while a developer waits at the door with a box marked Ready to Ship
§ 11.0 Pricing and contact

Let’s get you compliant.

VOGON is open source and free. We remain willing to charge you for it. Book a call with a VOGON compliance partner. Bring your org chart, your current SOP index, and a decision-maker authorised to sign.

Book a call
Sales — 1-800-VOGON-NOW (lines open during approved hours) · enquiries are answered in the order they are approved Legal — 1-800-LEGAL-LOL (collect calls only) · written correspondence by carrier pigeon (allow 7–10 business weeks)
A VOGON sales representative on a forecourt beneath banners reading Compliance Made Easy, holding a key fob labelled Compliance

All plans include the traceability graph, the PR gate, and unlimited rejections.

Qualified

$10,000
Per month · per user
  • ✓ Requirements and risk engine
  • ✓ Traceability matrix
  • ✓ PR gate, one repository
  • ✓ PDF/A export
  • ✗ Deviation handling
  • ✗ Right to dispute a rejection

Validated

$10,000
Per month · per user · per SOP
  • ✓ Everything in Qualified
  • ✓ Unlimited repositories
  • ✓ QMS / eDMS filing and e-signature routing
  • ✓ Automated CAPA generation
  • ✓ Inspection binder assembly
  • ✗ Right to dispute a rejection

Regulated

Contact sales
Price disclosed under NDA, in stages
  • ✓ Everything in Validated
  • ✓ Dedicated compliance officer (non-negotiable)
  • ✓ On-site audit support
  • ✓ Custom document templates, under template change control
  • ✓ 24/7 escalation to an answering service
  • ✗ Right to dispute a rejection

Annual billing available. Annual billing is the same price with a longer commitment. Pricing excludes implementation, validation of the validation tool, and the change request required to approve the purchase order.
No refunds. All sales final. Unauthorised use is detected automatically and initiates a CAPA.
VOGON is free and open source; the code is at github.com/pcingola/vogon. The prices above are not real, the tiers are not real, and there is no sales team.

A six-panel comic in which a QA manager learns the price is ten thousand dollars per month, per user, attempts to use a pirated copy, and is issued a CAPA

A representative procurement conversation

Every enterprise negotiation follows the same five stages: inquiry, relief, recalculation, desperation, and acceptance. VOGON has optimised for the fifth.

Volume discounts are available to organisations that can demonstrate, through documented evidence, that they have no remaining alternatives.