Built for ISO 13485 teams

Bring the QMS you already keep in Word, Excel and shared drives. Nirvan turns it into numbered, revision-controlled documents with approvals, training and an AI assistant that knows your system.

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Document No.

SOP-10004

Revision

C

Effective

—

Document Control

In review

1. Purpose — This procedure defines the controls for creating, reviewing, approving, issuing and withdrawing controlled documents.

Approvals

Quality Lead
e-signed 11 Oct 2026
Operations Lead
e-signed 12 Oct 2026

Halo — SOP-10004 Rev C is effective. 12 people are assigned training on it; none overdue yet.

Built for regulated environments

ISO 1348521 CFR Part 820EU MDRCE

You know this folder.

Every quality system starts in a shared drive. Nirvan reads what is already there and gives it numbers, owners, revisions and a status you can defend in an audit.

Your shared drive

  • Quality
  • QM Rev B FINAL.docx
  • ~$QM Rev B FINAL.docx
  • Copy of SOP-04 Doc Control v3 (1).docx
  • New folder
  • incoming inspection DRAFT mark edits.pdf
  • training matrix 2023.xlsx
  • Old versions (do not use)
  • calibration log USE THIS ONE.xlsx

No numbering, no owners, no revision history. Nobody is certain which copy is current.

Controlled document register

  • Quality Manual

    QM-10001 · Rev B

    Effective
  • Document Control

    SOP-10004 · Rev C

    Effective
  • Incoming Inspection

    WI-10011 · Rev A

    In review
  • Training Record

    FRM-10007 · Rev A

    Effective
  • Calibration Log

    FRM-10012 · Rev A

    Draft

One system,
start to finish

Import it, control it, train on it and ask Halo about it — without a six-month eQMS implementation.

01

Bring what you have

Upload your document register and a folder archive. Nirvan reads your Word and PDF files, keeps their numbering, revisions and revision history, and brings the content into the editor — not as dead attachments.

02

Documents become workflows

Every document gets an owner, approvers and a change order. Draft, route for review, e-sign, set an effective date, assign training — and keep the audit trail without leaving the platform.

03

Halo knows your system

Ask across your documents, change orders, approvals and training. Halo answers from your actual records, links straight to them, and briefs you on what needs attention today.

Meet Halo

Your AI-Powered QMS Assistant

Ask anything about your documents, change controls, trainings, and compliance status. Compare document versions, track approvals, and get daily briefings. Halo understands your entire quality system.

Conversational Q&AChange ControlDoc IntelligenceDaily Brief
Halo AIQ&A
How many documents do I have?
Ask anything...

The parts you only
notice in an audit

Signatures, history, permissions and records — already there when someone asks for them.

E-signature

Approvals signed in place, with the signer, their meaning and the timestamp retained against the revision.

Audit trail

Every action logged against the document, the change order and the person who took it.

Halo AI

Ask across your documents, change orders and training. Answered from your own records, with links to them.

Roles and permissions

Custom roles with granular permissions, so people see and approve only what their role allows.

Document controls

Your own prefixes, numbering rules, revision schemes and standing approvers per document type.

Test reports

Verification and validation records filed alongside the documents they belong to.

Start with a system,
not a blank screen

Four steps from a shared drive to a quality system you can run and defend.

01 / 04

Import your QMS

Upload your document register and a folder archive. Nirvan reads the Word and PDF files, keeps their numbering, revisions and revision history, and brings the content into the editor.

app.nirvan.ai

QMS Setup · Import

QL

Importing 24 documents

Extracting document numbers, revisions and revision history…

QM Rev B FINAL.docx

QM-10001 · Rev B

Copy of SOP-04 Doc Control v3 (1).docx

SOP-10004 · Rev C

incoming inspection DRAFT.pdf

WI-10011 · Rev A

02 / 04

Everything numbered and controlled

Each document lands with its own number, revision and owner. Prefixes and numbering follow the controls you set, so the register is consistent from the first import onward.

app.nirvan.ai

Controlled Documents

QL

Quality Manual

QM-10001 · Rev B

Effective

Document Control

SOP-10004 · Rev C

Effective

Incoming Inspection

WI-10011 · Rev A

In review

Training Record

FRM-10007 · Rev A

Effective

Calibration Log

FRM-10012 · Rev A

Draft

03 / 04

Route changes for approval

Changes move through a change order. Link the affected documents, assign approvers, collect e-signatures, then set an effective date and release the controlled version.

app.nirvan.ai

DCO-10042 · Revise Document Control

QL

Routing for approval

In review
DraftIn reviewApprovedEffective

Approvers

Quality Lead
Approved
Operations Lead
Approved
Regulatory
Pending

04 / 04

Train the people affected

An effective revision triggers training for the roles that need it. Completion is tracked per person and per group, so you can show who was trained on which revision.

app.nirvan.ai

Training · SOP-10004 Rev C

QL

12 assigned

Due 26 Oct 2026 · none overdue

7/12

complete

Production4/4
Quality2/3
Engineering1/5

Start small. Grow into Nirvan.

Nirvan is free while we are in early access. Pricing below is indicative and will be confirmed before any plan starts billing.

Self-service

Starter

$20 / user / month

Indicative · free during early access

  • Controlled documents with a rich native editor
  • Revision control, numbering and revision history
  • Change orders with approvals and e-signature
  • Training plans, assignments and records
  • Import from Word, PDF, Excel and folder archives
  • Halo AI across your quality system

Growth

Talk to Us

For larger regulated teams

  • Everything in Starter
  • Custom roles and granular permissions
  • Guided QMS import and onboarding
  • Priority support

Get your quality system
out of folders.

Bring what you already have. Nirvan takes it from there.

Free during early access · No credit card