eQMS Sprint • 10 Working Days • One Workflow

Don't buy a quality system.
Start with one workflow.

Most eQMS projects begin with a nine-month selection and end with a system that holds the same gaps the old one did. The Sprint runs the other way round. Ten working days, one real process of yours, and a written answer at the end - including the answer that says not yet.

Workflow

your real one, running as it runs today

Working days

fixed scope, fixed price

Obligation

to buy anything at the end of it

Before we talk about software

Four questions.
If any of them makes you pause, the Sprint is for you.

"Can you show me every action that came out of that complaint?"

If the honest answer involves opening four systems and asking two people, the records exist but the thread does not.

"Which CAPAs closed without effectiveness evidence?"

This is the single most cited observation in device inspections. Most teams can only answer it by reading the file.

"That change is approved - did the revalidation ever happen?"

Open revalidation debt is a live nonconformity on every unit shipped since. It usually surfaces at exactly the wrong moment.

"How long would it take you to prepare for an inspection next month?"

If the number is measured in weeks of evenings, the problem is not effort. It is that the evidence was never connected as the work happened.

What actually happens

Ten days.
You are in the room for
about four hours of it.

We do the work. You give us the process and two short sessions.

Everything below is fixed - no discovery phase that quietly becomes a project.

Day 1 · 90 Min

Walk the workflow

One call. You take us through one process exactly as it runs today - CAPA, complaint, change control, document control, training or supplier quality. Not the SOP version. The real version, including the spreadsheet and the WhatsApp message.

Days 2–3

Map it honestly

We draw the process as it is: where ownership changes hands, where approvals wait, where records disconnect, and what evidence each stage is actually required to produce under 21 CFR Part 820 (QMSR) and ISO 13485.

Days 4–6

Run it through the rules

We take an export of your records for that one workflow - or a de-identified sample if you prefer - and run it against the governed rule library. Every check cites its rule and the regulation behind it. Where the data is too thin to be sure, we say so instead of scoring it.

Days 7–8

Build it in TRACE

Your workflow, configured and running: the stages, the gates that stop closure, the electronic signature, and the links to whatever else it touches. You see your own process, not a generic demo.

Days 9–10 · 2 HRS

Playback and decide

One session with your team. We walk the findings, show the same workflow running in TRACE, and hand over the written report. Then you decide. Nothing is presented for signature on the day.

What you keep

Five things - and they are yours whether you buy or not.

Your workflow, mapped as it really runs

One page. Ownership, hand-offs, decision points and the places the process quietly depends on a person rather than a system.

PDF · Yours to reuse

The evidence each stage must produce

Stage by stage, what a regulator expects to exist - and which of those you currently generate, which you generate late, and which you do not generate at all.

Mapped to 820 / ISO 13485

A gap report you could hand to an auditor

Every finding names the rule, the regulation, the affected records and what would close it. No opinions, no severity theatre.

Deterministic · Reproducible

Your process running inside TRACE

Configured, with the real gates and signatures live. Use it in the playback session, and use it again internally to make the case - or not.

Live environment · 30 days

A written recommendation, signed by us

Go, phase it, or don't. If the answer is that you have a process problem rather than a software problem, that is what the document will say.

The part that matters

Live Sample - From a gap report

CAPA workflow - evidence gaps 47 records · 10 governed rules · evaluated 20 Mar 2026

RS-CAPA-INDEPENDENCE v1Medium · Weight 1.0

4 of 47 records

Same person investigated and verified

Basis: 21 CFR 820.100 / 820.20 - verification is expected to be independent of the person who performed the work.

Four CAPAs show one name in both the investigator and verifier fields.

To close it: Enforce segregation of duties at the signature, not in a monthly report.

psychology eQMS Workflows

Pick the one workflow that costs you the most sleep.

CAPA · Complaint handling · Change control · Document control · Training · Supplier quality · Nonconformance

verified

CAPA

Corrective and Preventive Action workflow with root cause investigation, effectiveness verification, and audit-ready traceability.

chat_error

Complaint Handling

End-to-end complaint intake, investigation, and closure with regulatory reporting triggers and action tracking.

swap_horiz

Change Control

Formal change request, impact assessment, approval routing, and revalidation tracking for regulated environments.

description

Document Control

Version-controlled document lifecycle with review, approval, distribution, and obsolescence management.

school

Training

Competency management, training assignment, completion tracking, and re-certification workflows for personnel.

inventory_2

Supplier Quality

Supplier qualification, performance monitoring, audit scheduling, and nonconformance management for vendors.

warning

Nonconformance

Nonconforming material identification, segregation, disposition, and CAPA linkage with regulatory compliance.

Step 1: Today

One email. Name the workflow and why.

Step 2: 45 Minutes

We reply with a date, a fixed price and the two slots we need.

Step 3: Day One

Ninety minutes. We walk your process and the Sprint starts.

Don't buy a quality system. Start with one workflow.