HOW IT WORKS

When the inspector asks who authorized this and why, this is the record that answers.

Your quality systems preserve what happened. ComplianceWorxs preserves why it was authorized: the Record Behind the Decision.

A Quality leader walks a reviewer through an approved decision record on a laptop: who authorized it, the evidence reviewed, and the risk considered.

Test one of your own decisions See a completed record

THE INSPECTOR ASKS

Who authorized this, and why?

CAPA closure · Batch release · Deviation disposition

WHAT THE FILE USUALLY SHOWSTHE RECORD ANSWERS

Select a question to see what it means and how the record solves it.

WITHOUT THE RECORD

The records exist, but no one can show which ones the decision rested on. Asked to prove it, you start searching.

You search the files.

WITH THE RECORD

The record lists the evidence considered, tied to the decision, at the time it was made.

You hand over the record.

WITHOUT THE RECORD

The reasoning lives in a reviewer's head. Under questioning it becomes a story told after the fact, and the alternatives you rejected go unmentioned.

You explain from memory.

WITH THE RECORD

The reasoning and the rejected alternatives are written down, then pressure-tested, before the record is preserved.

You point to what was written.

WITHOUT THE RECORD

Accepting a risk looks the same as overlooking it. The file shows an approval, not the weighing behind it.

Accepted risk looks overlooked.

WITH THE RECORD

The risk evaluation and the known limitation are stated in the record, with who accepted them.

Accepted risk is on the record.

WITHOUT THE RECORD

A signature shows a name, not the authority. If the signer has left or is unsure, nobody can answer who authorized this.

Nobody can answer.

WITH THE RECORD

A named decision owner, a timestamped authorization, and the boundary of what was approved.

The answer is on the page.

The gap is undocumented authorization reasoning. See the record that closes it →

CAPTUREThe reasoning, while the decision is being made

PRESSURE-TESTAgainst regulatory expectations

PRESERVEAs the permanent, inspectable record

ANSWERWho authorized this, and why

THE RECORD

One decision. Four questions. One record an inspector can read.

The Inspection Response Record covers one critical GMP decision. Each question has a place in the record, and each has a page that explains it.

DecisionWhat was decided, and what it covers

Regulatory context21 CFR Part 11, Annex 11, GAMP 5

TimestampAuthorization recorded when it was given

Evidence

What evidence was relied upon.

Understand Evidence →

Judgment

Why this path, and which alternatives were rejected.

Understand Judgment →

Risk

How risk was weighed, and what limitation remains.

Understand Risk →

Authorization

Who had the authority, and what they approved.

Understand Authorization →

THE INSPECTOR'S QUESTION Who authorized this, on what evidence, how was risk weighed, and why was it justified?

THE SITUATION

The work is complete. The reasoning behind the authorization is gone.

Most organizations can show that an investigation closed, a CAPA was approved, or a batch was released. The inspection risk is not poor compliance. It is authorization reasoning that was never written down, so it gets reconstructed.

WHAT YOUR QUALITY SYSTEM SHOWS

OutcomeClosed / Approved / Released

StatusWorkflow complete

SignatureApproval captured

WHAT THE INSPECTOR STILL ASKS

EvidenceWhat evidence did they rely on?

JudgmentWhy this decision and not another?

RiskHow was risk weighed?

AuthorizationWho authorized it, and on what authority?

THE NEXT ACTION

Choose where to start.

DIAGNOSE

GMP Decision Assessment

Use when you want to find where one of your decisions becomes hard to explain. Takes about three minutes.

Test one of your own decisions

PRESERVE

Inspection Response Record

Use when one critical GMP decision needs the record behind it now. It also produces the Authorization Record, Response Kit, Investigator Challenge Guide, and Executive Brief.

Create an IRR — $497

ESCALATE

Executive Briefing

Use when the exposure is broader or active, such as a Form 483 or an upcoming inspection. Ask the assistant first; a person is available within one business day.

Request an executive briefing

THE DECISION

Can your organization show who authorized the decision, and why, from the record that exists?

Can the record alone answer: who authorized this, and why?

YES

The record already answers

The evidence, judgment, risk, and authorization are written down, connected, and dated when the decision was made.

NO / NOT CLEAR

The reasoning would be reconstructed

Separate what was recorded at the time from what someone would have to remember, assume, or explain later.

■ Evidence ▲ Judgment ● Risk Authorization

THE MECHANISM

Capture it. Pressure-test it. Preserve it. The sequence is the point.

Reasoning captured after the decision is reconstruction. Reasoning captured but never tested is opinion. ComplianceWorxs does not replace your QMS, CAPA, or deviation systems. It sits above them and keeps what they never capture.

Capture the reasoning

Record who authorized the decision, the evidence considered, the alternatives weighed, and the risk evaluation while all of it is still available.

Pressure-test it

Check whether the reasoning is supported by evidence, addresses reasonable alternatives, and can stand up to regulatory scrutiny.

Preserve it as the record

It becomes the timestamped, inspectable record of the authorization, written so an inspector can read it without anyone in the room to explain.

THE RECORD BEHIND THE DECISION

The Inspection Response Record protects one decision. Membership protects every decision as it is made.

See a completed record Create an IRR — $497