Electronic records & signatures controls
Validation of systems to ensure accuracy, reliability, and consistent intended performance, plus audit trails, authority checks, and device checks — all present, or the package does not release.
The most rigorous CSA/CSV validation package a regulated company can buy.
The GxP Validation Engine assembles an audit-ready validation package — validation plan, GAMP 5 risk assessment, requirements & traceability matrix, CSA-aligned test protocols, and validation summary report — checked against 21 CFR Part 11, Part 820 (QMSR), EU Annex 11, and FDA's final Computer Software Assurance guidance before a qualified validation engineer signs off.
Every applicable subsection of 21 CFR Part 11 & Part 820GAMP 5 risk classification, gate-checkedAI drafts 80–90%; expert signs every releaseFixed fee per validated system — never hourly5-business-day SLA
Why validation fails
A single missing trace or risk gap can trigger a 483 or warning letter.
Every FDA-regulated company that touches a GxP computer system must validate it — a legal obligation under 21 CFR Part 11, the new Quality Management System Regulation (QMSR / 21 CFR Part 820, effective Feb 2, 2026), and EU Annex 11. Historically, validation is done by armies of consultants writing hundreds of pages of protocols by hand, billing by the hour. That model is breaking: validation team workload is up while headcount is down, skilled validation engineers are scarce, and the migration of GxP work onto cloud SaaS multiplies the number of systems that need validating.
Most companies run validation by hand, from memory, once or twice a year. The regulations have not been read end-to-end since the last audit. That is exactly where completeness gaps hide.
The GxP Validation Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
66% / 46%
of validation teams report workload up / headcount down
The benchmark
Measured against the letter of the regulations — subsection by subsection.
We do not summarize the law and hope. Every validation package is scored against a versioned rule pack tied to the exact text of 21 CFR Part 11, Part 820 (QMSR), EU Annex 11, and FDA's final Computer Software Assurance guidance. These are the provisions each package is held to.
Design controls & software validation
Requirements for design planning, input, output, review, verification, validation, and design transfer — integrated into the validation plan and traceability matrix.
Risk-based validation rigor
Validation documentation to reflect a risk assessment that determines the extent of validation needed — GAMP 5 category classification is applied deterministically.
Critical thinking over paperwork
Test protocols aligned to the FDA's risk-based assurance approach: focus on patient safety and product quality, not exhaustive scripted testing of every function.
Good Automated Manufacturing Practice
Lifecycle approach from concept to retirement, including supplier assessment, risk management, and traceability — each deliverable mapped to GAMP 5 stages.
Legacy systems & hybrid controls
For systems predating Part 11, documented justification and alternative controls — sequenced and evidenced in the validation summary report.
How a validation package is built
Intake to expert release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified validation engineer and QA reviewer sign every release. That order is never reversed.
01
Validation Gap Scan
Upload system requirements, configuration, and vendor documentation. We return a free completeness read: which regulatory elements and risk assessments you already have, and which are missing.
02
Evidence & risk classification
As your authorized clerical agent, we collect system specifications, vendor test evidence, and user requirements. We classify the system per GAMP 5 (Category 1–4) and determine validation rigor.
03
Grounded drafting
The six core document types are drafted from your validated data and the regulatory rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Requirements trace to test scripts; risk assessments map to GAMP categories; the 21 CFR Part 11 checklist is resolved; any gap blocks release.
05
Expert release
A qualified validation engineer reviews the exception queue and signs the release. A QA reviewer approves before the client's quality unit e-signs.
06
Delivery
You receive the validation package: validation plan, GAMP 5 risk assessment, requirements & traceability matrix, CSA-aligned test protocols/scripts, validation summary report, and a 21 CFR Part 11 compliance checklist — ready for your quality unit to review and e-sign.
The bar we hold
Rigor you can measure.
100%
Expert-signed
No package ships without a qualified validation engineer and QA reviewer signature.
5 days
Standard SLA
From complete intake to released validation package.
<1%
Critical-defect target
Tracked against a gold-standard validation package library.
6
Core document types
Validation plan, risk assessment, requirements & traceability matrix, test protocols, summary report, Part 11 checklist.
Why GxP Validation Engine
Built to be the most thorough option a regulated company has.
Documentation-complete, by design
The deliverable is completeness itself — every regulatory element and risk assessment accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run risk assessments as your clerical agent. We never make patient-safety decisions, give legal advice, or substitute for your quality unit's e-signature.
Engagement
Flat fee, per released validation package. No hourly billing, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Validation Gap Scan before you commit — see exactly what is missing.
- One flat fee per released validation package; disclosed pass-through costs for any third-party testing.
- Optional fixed-fee attorney review for high-risk or novel systems.
- Optional Change Control Retainer for ongoing validation maintenance and revalidation.
FAQ
Questions, answered precisely.
Is GxP Validation Engine a law firm?
No. GxP Validation Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-risk or novel systems.
Do you make patient-safety decisions or substitute for our quality unit?
Never. GxP Validation Engine is not a quality unit and does not make patient-safety or regulatory-compliance decisions. Your quality unit retains full responsibility for e-signing and approving the validation package.
What makes a validation package 'complete'?
Completeness is defined by the regulations: the six core document types present, GAMP 5 risk classification applied, requirements traced to test scripts, 21 CFR Part 11 checklist resolved, and deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to an expert-released validation package. The free Validation Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released validation package, plus disclosed pass-through costs. No hourly billing and no percentage of any system cost or revenue.
See what's missing before it costs you a 483.
Start with a free Validation Gap Scan. Send your system requirements, configuration, and vendor documentation and we'll return a completeness read against every applicable subsection of 21 CFR Part 11, Part 820, EU Annex 11, and FDA's CSA guidance.
Documentation-completeness service · not legal advice · your quality unit retains final approval.