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Decision Record Workspace

See which quality decisions need attention — and what to do next.

Decision Record Workspace gives Quality leadership one place to see which important decisions are weak, why they matter, who owns the next action, what is overdue, and whether the same problems keep recurring.

The Workspace opens in a demonstration environment built on a fictional organization and synthetic data. Nothing in it is a real customer record.

What it answers

The questions Quality leadership has to answer every week.

What needs my attention?

The decisions, records and commitments that cannot wait, ordered by consequence rather than by date.

Why is this decision weak?

What is missing from the record, in plain English, and what it would cost to explain the decision later without it.

Who owns the next action?

A named owner on every open item — the person who has to do the next thing, not just the department it sits in.

What is overdue or stalled?

Records sitting too long in one state, and conditions a decision was accepted on that have not been met.

Is the same problem happening repeatedly?

Whether this month’s finding is a one-off or the fourth month running of the same recording failure.

Which decision types, sites or functions are driving it?

Where the pattern concentrates, so the fix goes to the part of the organization actually producing it.

The view

What Quality leadership sees when they open it.

The executive view of the Workspace, shown here with example figures. Every number opens the decisions behind it — what they were, who owns them, and what is due next.

ComplianceWorxs / Decision Record Workspace Example data · 90-day view
Decisions assessed 24 Last 90 days
Decisions with material gaps 9 38% of assessments
Open records 5 2 awaiting authorization
Outstanding commitments 4 1 overdue

What needs attention

Ordered by consequence
Record · Awaiting authorization Sterility excursion disposition, Batch 24F-118 Owner: Maya Chen · Due today
Commitment · Overdue Grade A operator cohort requalification — 10 days overdue Owner: Sofia Lindgren · Next campaign starts Aug 26
Assessment · Material gaps Supplier exception — stopper dimensional variance Owner: Daniel Ruiz · 2 material gaps identified

Problems that keep happening

Last 90 days
Evidence Connection 7 Does the record show which evidence the decision actually relied on?
Decision Reasoning 6 Does it explain why the evidence supported the decision that was made?
Risk Judgment 4 Does it show what uncertainty or residual risk was accepted, and why?
Alternatives 3 Does it show what other options were considered and why they were not chosen?
Authorization 2 Does it show who had authority to make or approve the decision?

How it fits together

Assess → Strengthen → Govern → Monitor

One connected workflow, not four separate tools. The assessment finds what is weak in a decision, the record fixes it, and the Workspace manages what that means across the organization.

01

Assess

DDA / DRA

Identify what is weak in one important decision — which part of the reasoning the record does not preserve.

Assess a decision →
02

Strengthen

IRR

Create and govern The Record Behind the Decision — evidence, reasoning, risk judgment, alternatives, conditions and authorization for that one decision.

See the IRR →
03

Govern

Decision Record Workspace

Manage those decisions, their owners, their commitments and their recurring patterns across the organization.

Explore the Workspace →
04

Monitor

Workspace · Case Files

Watch whether the same problems keep happening, and compare against Case Files — worked reference examples of the same decision types.

See the Case Files →

Getting decisions in

No QMS or LIMS integration required.

You can use the Workspace without connecting anything. Decisions come in one of four ways, and each one keeps the source reference back to the record it describes.

Manual entry

Capture an important decision at the point it is made, while the reasoning is still current.

Document upload

Start from an investigation, deviation or change summary you already have.

CSV / XLSX import

Bring a list of decisions across from a spreadsheet or an export from another system.

DDA / DRA → IRR

An assessed decision moves into the Workspace natively, with its findings and owner attached.

Optional future connections

Your source records stay where they are today. Over time, the Workspace may optionally connect to systems you already run so a decision can be raised from them automatically — for example Veeva · TrackWise · MasterControl · Valdata · LIMS · MES · ERP.

None of these connections exists today. None is connected, and none is required to use the Workspace.

What it is not

Where the Workspace stops.

It does not replace your QMS, LIMS or document repository.

Those systems keep doing what they do. The Workspace sits alongside them and holds the management view of the decisions they record.

Your GMP and source records stay in your systems.

The Workspace references a source record by its own identifier. It does not become the repository of record for your GMP documentation.

It is not a compliance guarantee.

Nothing here certifies compliance, and no output is a regulatory determination. It shows you what your own records do and do not preserve.

It makes no Part 11 or electronic-signature claim.

Workflow states shown in the Workspace are management states. They are not a regulatory electronic signature.

Know which quality decisions need attention before they become inspection problems.

Open the Workspace and look at a worked organization, or start with a single decision and see what your own record preserves.