Quality (QMS)

Getting set up

Set up your quality management system

Connect Forms, Processes, Controls and Vault workflows

Run the initial QMS setup wizard

Set up QMS with the AI advisor

Complete setup for each QMS standard

Link evidence to requirements

Investigate coverage gaps across standards

Documents

Create and approve a QMS document

Edit, review and export document content

Import existing quality documents

Configure QMS document types

Explore a standard’s document-type hierarchy

Generate a standard’s documents with AI

Create documents with the QMS wizard

Build the section structure of a blank QMS document

Edit and save QMS document content

Review sections and discuss document changes

Inspect and restore section content history

Download a QMS document as PDF or Word

Publish, approve and revise a controlled document

Insert and resolve document property tokens

Ask the document editor AI for targeted changes

Compare and review AI document changes

Check document quality and recorded references

Document editor AI preference reference

Create, edit and save document diagrams

Review, compare and restore diagram versions

Set document language and navigate translations

Create and monitor document translations

Review translations and manage source changes

Processes

Define and approve an operational process

Design and improve processes with AI

Configure process steps, responsibility and completion

Start, cast and complete a process run

Follow decisions, parallel paths and rework

Review the record of a completed process run

Schedule recurring process runs

Forms and records

Find and manage forms for a standard

Complete and submit a standard form

Save, resume and recover form drafts

Review form submissions and automatic outputs

Design and maintain QMS form fields

Configure form options, calculations and conditions

Organise QMS form sections

Configure form settings and inspect the preview

Configure and maintain form output rules

Configure each form output action

Tasks, recurring work and CAPA

Manage quality tasks and recurring obligations

Create and maintain recurring task definitions

Understand recurring task schedules and due dates

Create a recurring task from an AI suggestion

Complete, skip and reschedule recurring task instances

Review recurring work in the task calendar

Manage corrective and preventive actions

Create, complete and verify CAPA actions

Review CAPA workflows, severity timings and sources

Use the root cause analysis tools

Audits and management review

Plan an audit programme and engagement

Create and review audit programmes

Define audit scope and build the audit team

Plan audit sampling and record conclusions

Record observations and collect audit evidence

Create, respond to and close an audit finding

Review audit trends and continuous monitors

Configure and evaluate continuous audit monitors

Prepare external audit evidence and practise interviews

Set up a standard-specific mock audit

Knowledge, facts and AI chat

Work with the AI assistant for a QMS standard

Find, archive and delete QMS conversations

Choose and search a standard's knowledge sources

Find and assess QMS facts

Capture, edit and review QMS facts

Read QMS news and announcements

Settings, roles and notifications

Configure quality standards and assignment rules

Review automatic assignment rules and their limits

Assign and verify QMS user roles

Review QMS notification preferences

Read and manage notifications from QMS