The fastest way to a first draft in Formwork is to ask the AI Assistant for one. It writes into Formwork directly: the result is a normal draft document, record or item, with you as its author, sitting in the folder or release you named, ready for the review process you already use.
Drafting a document or record
Open the AI Assistant and describe what you need, including where it goes and what it should be based on:
- "Draft an SOP for supplier evaluation in the Purchasing folder. Base it on our template and our supplier criticality classes A, B and C."
- "Create a record for today's management review in Management Reviews. Attendees: ...; topics: ...; decisions: ..."
- "Write a training record for the ISO 14971 training held on 3 September for the roles QA and Development."
The assistant creates the draft and answers with a link. Open it, read it, and edit it in Formwork like any other draft, or ask the assistant for changes while it is still a draft ("make the scope section shorter", "add a step for re-evaluation after a non-conformity").
A few things that help:
- Point at a template or an existing document. "Use our SOP Template" or "structure it like SOP Document Control". The assistant reads what you name and follows it.
- Give it the facts. Names, dates, decisions, numbers. The assistant is good at structure and wording, not at knowing what happened in your meeting.
- Say which folder. Without one, the assistant asks or uses a sensible default; naming it saves a round trip.
- Records for a product release: say the product and release ("for release 1.2 of the pump"), otherwise the record is created as a QMS-wide record.
A new version of an approved document
Approved documents and released records cannot be edited, by you or by the AI. Ask for a change anyway and the assistant does what you would do manually instead. For approved documents, the AI creates a new draft version. For released records, this is only possible when the record was carried over unchanged from a previous product release. Other released records must be amended directly in Formwork.
"Update SOP Document Control: the retention period in section 5 changes from 10 to 15 years." creates version n+1 as a draft with that change, and tells you where it is.
Drafting technical documentation items
The same works for anything in a product release: stakeholders, user needs, requirements, tests, hazards, hazardous situations, harms, risk table entries, risk controls, failure modes, change requests, incidents. The assistant links items to each other when you tell it to ("...and link them to the existing harm Overdose").
- "Create three hazards for the battery subsystem of release 2.0 and link each to the user need UN-4."
- "Write a software test for DI-17 with steps and expected results."
- "Add a risk control of kind protective measure for RTE-9: ..."
For a whole first set of user needs, requirements or tests, the Autogenerate buttons on those pages and the "Start with AI-generated content" option when creating a product are usually quicker; see Use AI to create your technical documentation.
Sending a draft for review
Once you are happy with a draft, ask the assistant to send it: "Send the supplier SOP for review to the QA role with the comment 'first version, please check section 4'." It creates the review request; approving or rejecting stays with the reviewers. For technical documentation items, reviews are sent per list ("send the hazards of release 2.0 for review"), never for a single item.
Reviewing what the AI wrote
AI output is a draft, and a draft written quickly. Before sending it on:
- Check facts, not just wording. Dates, responsibilities, references to other documents, regulatory citations.
- Read the parts you didn't ask for. The assistant fills gaps with plausible text; that text is not yet your process.
- Use tasks for open points. "Create a task for each assumption in this draft that we still need to confirm" gives you a checklist instead of TODO markers in the text.
- Diff against the previous version when the assistant created a new version of an existing document, to make sure only the requested change happened.
Every draft the assistant creates counts one prompt per message you sent; see AI Usage & Limits. For editing an existing draft paragraph by paragraph with a visible diff, use the AI Document Editor: Editing with AI.