Platform
An Audit Readiness Workspace Built on the Documents You Already Have
QMSAdvisor sits beside your quality system, not in place of it. Upload what you have, see advisor-reviewed findings with their sources, work an action plan with your advisor, and keep a record of how every gap was closed.
The Workflow
One Path From Upload to Accepted Evidence
Every finding follows the same path, and every step on it is recorded.
Step 1: Documents
Upload the quality documents you already have: procedures, records, spreadsheets and exports from your current eQMS. Nothing is migrated or rewritten. Original files are preserved and fingerprinted.
YouStep 2: AI First Pass
AI-assisted gap analysis reads every document against QMSR, ISO 13485 and the standards in scope, and drafts candidate gaps. Each one points to the document and passage it came from.
AI first passStep 3: Advisor Review
A qualified QMS advisor reviews every draft, discards what doesn't hold up, adds what software can't judge and sets severity. Nothing reaches you until the advisor publishes it.
AdvisorStep 4: Findings
Advisor-reviewed findings, each with the requirement, the source, a severity, a gap type and a plain checklist of what to submit to close it.
AdvisorStep 5: Client Action Plan
Findings become a working plan with owners, due dates and evidence requirements, sorted so the riskiest gaps are handled first.
You and your advisorStep 6: Evidence
Your team submits evidence against each finding: a revised procedure, a training record, a completed validation. A resubmission has to say what changed.
YouStep 7: Advisor Approval
The advisor accepts the evidence or returns it with a note. Every decision is written to an activity history that can't be edited after the fact.
AdvisorStep 8: Audit Readiness
A readiness view by area, a rehearsal in the inspection simulator, and a record that shows an auditor exactly how each gap was found and closed.
You and your advisor
The dashed label marks the only step software does on its own. Every step after it runs through a person.
Document Library
Your Documents, Exactly as You Supplied Them
- Upload procedures, records, spreadsheets and exports from the eQMS you use today. No migration and no reformatting.
- Original files are preserved byte for byte. What the advisor reviewed is what you uploaded.
- Each file gets a SHA-256 fingerprint, so a document can be shown to be unchanged since upload.
- Duplicate files are flagged, so the same procedure isn't reviewed twice under two names.
- SOP-QA-012 Complaint Handling rev C.pdfSHA-256 9f2c41e0…b7a3Original preserved
- SOP-QA-015 CAPA rev D.docxSHA-256 4be81d27…0c19Original preserved
- Supplier list 2026.xlsxSHA-256 c03a9f55…e42dOriginal preserved
- CAPA procedure (export).pdfSHA-256 4be81d27…0c19Duplicate of SOP-QA-015
- Mgmt review minutes Q2.pdfSHA-256 71d0e6b8…5f8eOriginal preserved
Complaint files do not record the MDR reportability decision
- Requirement
- Complaint handling under QMSR and ISO 13485; 21 CFR Part 803
- Source
- SOP-QA-012 rev C, complaint evaluation section
- Owner
- QA Manager
- Due
- In 21 days
What to submit
- Submitted: Revised complaint handling procedure with a reportability decision step
- Submitted: Training record for complaint handlers on the revised procedure
- Not yet submitted: Five recent complaint files showing the documented decision
Consultant-Reviewed Findings
Every Finding Reviewed by an Advisor, With Its Source
The AI-assisted first pass drafts candidate gaps, each pointing to the document and passage it came from. An advisor reviews every draft: discards what doesn't hold up, adds what software can't judge, and sets severity. Only then is it published to your team.
- Severity
- Gap type
- Requirement and source
- Owner
- Due date
- What to submit checklist
Six Gap Types, Each With a Clear Way to Close It
| Gap Type | What It Means | Typical Evidence to Close It |
|---|---|---|
| Missing procedure | A required procedure does not exist. | A new, approved procedure and training on it |
| Procedure inadequate | A procedure exists but does not meet the requirement. | A revised procedure that does |
| No evidence | The procedure exists, but no records show it is followed. | Records from performing the procedure |
| Insufficient evidence | Records exist but do not fully show the requirement is met. | Complete records, or records from more instances |
| Inconsistency | Documents contradict each other, or practice contradicts the documents. | Aligned documents and a note of what changed |
| Training gap | People have not been trained on the current procedure. | Training records for the affected roles |
Client Action Plan and Evidence
A Plan Your Team Can Work, and an Advisor Who Signs Off
Findings become an action plan sorted by severity, then due date. Your team submits evidence against each one, and the advisor accepts it or returns it with a note. A resubmission has to say what changed.
| Finding | Severity | Owner | Due | Status |
|---|---|---|---|---|
| F-003No procedure for corrections and removalsMissing procedure | Critical | RA Lead | Oct 24 | In progress |
| F-014Complaint files lack reportability decisionInsufficient evidence | High | QA Manager | Oct 31 | Awaiting review |
| F-021Supplier risk basis not documentedProcedure inadequate | Medium | Supply Chain | Nov 14 | Revision requested |
| F-027Training on revised CAPA SOP not recordedTraining gap | Low | HR / QA | Nov 21 | Accepted |
A draft from the first pass. Only the advisor sees it.
Reviewed and published by the advisor. Now it's a finding.
Your team has submitted evidence for review.
The advisor accepted the evidence and closed the finding.
AI drafts never reach your team until an advisor publishes them. Deferring a finding or marking it not applicable requires a written reason. The action plan exports to CSV.
CAPA Records
A CAPA Record That Shows the Whole Chain
When a finding needs corrective and preventive action, the CAPA record keeps the four parts an investigator asks about in one place, linked to the finding, the evidence and the advisor's decisions.
- 01
Correction
What was done right away to fix the immediate problem and contain affected product.
- 02
Root Cause
The investigation and the method used to get from the symptom to the cause.
- 03
Corrective Action
What was changed to stop it happening again, across every product and process it could affect.
- 04
Effectiveness Verification
The criteria set in advance, and the evidence that the action worked.
Comments, Notifications and History
A Record of Every Decision That Can't Be Rewritten
- Comment on a finding in context, instead of in an email thread nobody can find later.
- Notifications when something is assigned to you, returned to you or waiting on you.
- Every upload, finding, submission, revision request and approval is written to an append-only activity history.
- When an auditor asks how a gap was closed, the answer is one page, with dates and names.
- Oct 18, 10:42 · AdvisorAccepted evidence for F-027 and closed the finding
- Oct 17, 16:05 · QA ManagerResubmitted evidence for F-021. What changed: added supplier risk ratings
- Oct 15, 09:30 · AdvisorRequested revision on F-021: risk basis not shown for two critical suppliers
- Oct 14, 14:12 · QA ManagerSubmitted evidence for F-021 (2 files)
- Oct 9, 11:00 · AdvisorIssued 27 findings from the AI-assisted first pass
Entries are append-only. They can't be edited or deleted.
Response due
9 business days left
Counted from the inspection close date you entered
Day 6 of 15
- Observation 1CAPA effectiveness not verifiedDraft response
- Observation 2Complaint investigations incompleteEvidence in review
- Observation 3Supplier evaluation records missingResponse ready
Form 483 and Warning Letter Tracker
The 15-Business-Day Clock, Visible to Everyone
FDA asks firms to respond to a Form 483 in writing within 15 business days after the inspection closes for the response to be considered, and warning letters usually ask for a response within 15 business days of receipt.
Enter the close date or the receipt date and the tracker counts business days down. Each observation gets its own response item, linked to the findings and evidence behind it, and a draft response composer helps assemble the reply for your team to finalize and sign.
Multi-Client Portfolio for Consulting Firms
Quality and regulatory consultancies can run several clients from one portfolio: each client's documents, findings and action plan in its own workspace, with a review queue across all of them.
Tenant Isolation and Private Storage
Each client organization is isolated from every other. Files are held in private storage that isn't publicly reachable, and access is limited to your team and your advisor. Ask us for the details of how your data is handled before you upload anything.
How the AI Is Used
AI-assisted analysis is a first pass. It reads your documents and drafts candidate gaps, each with a source. It doesn't decide what's a gap, doesn't set severity and doesn't accept evidence. Every result is reviewed by a qualified advisor before it reaches you, and the platform enforces that order.
Next Step
See the Workspace With Your Own Documents
An assessment is the quickest way to see the platform working on your quality system. Please don't send confidential documents yet: secure upload is set up after onboarding.
