About ComplianceWorxs

What Is ComplianceWorxs?

Most FDA inspections don't fail because the decision was wrong. They fail because no one can prove how the decision was made.

The Problem

Your records show what happened. They don't show who authorized it — or why that decision was justified.

An investigator asks who authorized the CAPA closure. You have the record. You have the signature. What you don't have is the documented reasoning — the evidence considered, the risk evaluated, the logic that justified the decision at that moment. That gap is what generates a 483. Not the decision. The missing authorization trail.

During FDA inspections, investigators routinely ask a question that compliance records are not designed to answer:

FDA Investigator Question

"Who authorized this decision, and what evidence did they review before making it?"

The batch record exists. The investigation report exists. The CAPA is closed. But the authorization trail — who evaluated the evidence, which regulatory standard applied, who formally approved the outcome — often does not exist as a documented event.

When investigators cannot find that record, they issue a Form 483 observation. Not because the decision was wrong. Because the decision was never documented as an authorization event.

What investigators actually ask

During FDA inspections, investigators routinely ask questions the quality system cannot answer directly. These questions are not about records — they are about authorization.

"Who authorized this deviation closure and what evidence was reviewed?" Deviation Closure Scenario →
"Who approved this batch disposition and what quality criteria were evaluated?" Batch Release Scenario →
"Who decided this CAPA was effective and under which standard?" CAPA Effectiveness Scenario →
"Who determined the change did not require revalidation?" Change Control Scenario →

Each question above links to a full inspection scenario showing the authorization gap and what investigators expect to find.

The Solution

ComplianceWorxs is the system that produces the authorization record.

ComplianceWorxs is built around one insight: there is a structural gap between what quality systems document and what investigators evaluate. Quality systems capture events. Investigators evaluate the decisions behind them.

ComplianceWorxs closes that gap by giving compliance teams the intelligence to understand where authorization gaps exist, and the infrastructure to document authorization decisions before an inspector asks.

It is not a QMS. It is not a document management system. It is the system that produces the authorization evidence those systems cannot generate on their own.

Authorization records address inspection expectations embedded in 21 CFR 211.192, EU Annex 11, and ICH Q10.

What an authorization record looks like

Authorization Record IRR-2024-0847

Decision Category Deviation Closure — DV-2024-219

Authorized By Director of Quality — [Named Individual]

Regulatory Standard 21 CFR 211.192 — Investigation of Discrepancies

Evidence Evaluated Investigation report · Root cause determination · CAPA verification plan

Authorization Timestamp Frozen at moment of decision — immutable

See what an Inspection Response Record contains

How investigators evaluate compliance decisions

Inspection questions investigators ask most often How inspection findings actually occur — Form 483 observations

How It Works

Three products. One connected system.

Step 1 — Free

Decision Ownership Assessment

A 3-minute diagnostic that identifies which compliance decision categories in your organization lack a documented authorization trail. Most teams discover gaps they did not know existed. Results are immediate and require no account.

Start the Assessment

Step 2 — $375 each

Inspection Case Files

Structured case files that reconstruct real inspection scenarios — the investigator's question, the record that existed, the authorization evidence that was missing, and what an inspector does with that gap. Each case file covers one decision category: batch release, CAPA closure, change control, OOS investigations, and more.

Browse Inspection Scenarios

Step 3

Inspection Response Record (IRR)

The record behind the decision — who made it, what evidence they evaluated, which regulatory standard applied, and when the decision was authorized. Written so the reasoning survives without the people who did the reasoning. If an investigator asks tomorrow, the record answers on its own.

See what an IRR contains

Step 1 Identify the gap Free assessment

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Step 2 Study the scenario Inspection case file

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Step 3 Produce the record Inspection Response Record

Who It's For

Built for the people who own inspection outcomes.

ComplianceWorxs is designed for compliance professionals in FDA-regulated pharmaceutical and biotech organizations who are personally accountable when an investigator asks a question the record cannot answer:

QA Directors and Quality Managers
Validation Leads and CSV Professionals
Regulatory Affairs Professionals
Compliance Officers preparing for FDA inspections

How It Differs From Existing Systems

QMS platforms like Veeva, MasterControl, and Greenlight Guru document that events happened. They do not document that decisions were authorized.

ComplianceWorxs is built around the gap those systems leave.

Quality systems document what happened. ComplianceWorxs documents who authorized the decision and what evidence justified it.

That is the record investigators expect to find. That is the record most organizations cannot produce. That is what ComplianceWorxs makes possible.

Inspection Intelligence Library FDA 21 CFR · EU Annex 11 · GAMP 5

FDA Inspection Questions QA Directors Are Asked Most Often → Common FDA Form 483 Observations in Pharmaceutical Inspections → Inspection Scenario Library — 20 Documented Authorization Gaps → Inspection Reconstruction Review — Test One Decision Against the Record →

Start Here

Find out where your authorization trail breaks down.

The Decision Ownership Assessment identifies your authorization gaps in 3 minutes.
Free. No account required.

Start the Assessment Browse Inspection Scenarios →

Free · No account required · Results in under 5 minutes

Identifies authorization gaps investigators typically find during inspection.