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Getting Started#

Seven steps take an empty account to a running audit program. Complete them in this order, because each step depends on the one before it.

An eighth step is optional. It connects an AI provider and turns on the writing assistance in the audit runner.

1. Build your organization#

Open Organizations and create your top-level organization, then add sites, areas, subareas and equipment beneath it.

The full tree is not required on day one. Create the sites you audit and the areas inside them, and add depth later.

At least one Site is required before you can generate reports.

See Organizations.

2. Adopt a standard#

Open Standards, find the standard you run, and select Adopt.

Adopting marks the standard as yours and creates a management system named after it and bound to it.

To see how a standard grades findings before adopting it, select the grade count in the Severities column.

If no standard governs the domain you are documenting, skip this step and create a management system with its own scale in step 3.

See Standards.

3. Configure the management system#

Open Management systems and open the management system you are using.

  • If it is bound to a standard, the scale is read-only and supplied by the standard. Confirm the grades and deadlines are what you expect.
  • If it has no standard, add your grades: a code, a label, the CAPA route each grade starts, the deadline in days, and whether the grade is a knock-out.

A management system with no grades cannot grade findings and cannot start a corrective workflow. Complete this step before continuing.

See Management systems.

4. Assign responsible people#

Return to Organizations and use the responsibility matrix to the right of each row. Each unit names an Auditor, a Quality lead and an Owner, per management system.

A blank cell inherits from the unit above, so setting the three roles on a site covers everything beneath it.

The Auditor determines who planned audits are assigned to. The Owner and Quality roles determine who CAPA tasks are assigned to.

See Organizations.

5. Create your questions#

Open Checklist items and add the questions you check. For each question set:

  • The question text
  • The answer type
  • The management system it belongs to
  • Its non-conformance rules: which answer is a deviation, and which grade it produces
  • Optionally, reference photos and help text

See Checklist items.

6. Build and publish a checklist#

Open Checklists and select New checklist, or select Auto-create to assemble one from the question bank.

In the designer:

  1. Enter a title and select the management system. Both are required.
  2. Add sections and fill them with questions from the bank.
  3. Add at least one planning rule: where the checklist is audited, at which level, and how often.
  4. Select Publish.

Publishing activates a checklist

A draft checklist plans nothing and cannot be selected for an audit. Planning rules take effect only after a revision is published.

See Checklists.

7. Check the calendar and run the first audit#

Open Calendar. Planned audits appear on the month grid, compiled from your planning rules.

Review the Needs attention panel at the bottom. It lists checklists that are not planned, match no unit, have no responsible person, or have no questions. Each entry names the object to correct. See Calendar for the full list of gap types and their fixes.

Then open Tasks, select an audit, and select Start. See Running an audit.

8. Optional: connect an AI provider#

Connect an AI provider to give your auditors two assists on the finding panel: a finding drafted from their keywords, and a check of whether the same deviation has been raised before.

Open System Integration and add one of:

Provider Also needs
OpenAI ChatGPT API key
Anthropic Claude API key
Google Gemini API key
Azure AI Foundry Endpoint and API key
Ollama (self-hosted) Host and API key

One is enough. The platform uses the provider you configured. It never sends your compliance data to a provider you have not connected.

Self-hosted Ollama keeps every request inside your own network, which is the option to choose where audit content may not leave your infrastructure.

Without this step the Compliance Platform works in full. Only the two assists in the audit runner are unavailable, and their buttons are not shown.

See System Integration and Running an audit.

Setup checklist#

Done Step
☐ At least one Site exists
☐ A standard is adopted, or a management system has its own grades
☐ Auditor, Quality and Owner are set per site, per management system
☐ Questions exist and carry non-conformance rules
☐ A checklist exists, has a management system and has questions
☐ The checklist has at least one planning rule
☐ The checklist is published
☐ The calendar shows audits and the gap panel is empty

Notes and limits#

  • A new account starts empty. There is no sample content to copy from.
  • No bulk import. Organizational units, questions and checklists are created in the interface, one at a time.
  • The interface is English. Content you enter is multi-language and can be auto-translated, see Multi-language content.