ReguWrite AIRegulatory and quality writing assistant
From regulatory knowledge to quality documentation.
An AI-assisted writing environment designed to help professionals prepare and review quality and regulatory documents.
Interactive prototypeInteractive preview below
⚙ Aperçu d’interface ReguWrite AI · fourni par le thème, textes dans assets/js/i18n
The problem
Quality documents take long to write and longer to review.
Authors search for requirements, reuse old templates and lose time on structure. Reviewers then chase missing information.
Blank-page effort
Each deviation or SOP starts from scratch or from an outdated template.
Scattered sources
Requirements, site procedures and past records sit in different places.
Review loops
Gaps surface late, after several rounds of comments.
Proposed workflow
A traceable drafting workflow
How the module is designed to fit into daily work.
Collect context
Record data, product, area and event.
Identify sources
Site procedures and applicable requirements.
Draft
Structured text with references for each section.
Check gaps
Missing information flagged before review.
Review
A qualified person approves or returns the draft.
Interface preview
Watch a deviation summary take shape
Six steps, from context to human review. Sample data only.
Interactive previews powered by sample content. No AI model, regulatory database or external system is connected. Names, records and values are fictional.
⚙ Démo interactive ReguWrite AI · fourni par le thème, textes dans assets/js/i18n
Capabilities
What it does, and what is still planned.
Each capability shows its current status.
Three-panel workspace
Sources, draft and review status side by side.
Interactive prototype
Section-level references
Each paragraph shows the sources it relies on.
Interactive prototype
Missing-information checks
Flags gaps such as an unconfirmed root cause or an unassigned reviewer.
Interactive prototype
Human review step
Nothing is final until a qualified person reviews it.
Interactive prototype
Document templates
SOP, deviation, CAPA, change control and validation formats.
Planned
Site terminology
Drafts that follow your document conventions.
Planned
Audit response drafting
Structured responses to observations.
Planned
Document system integration
Export to your eQMS or document management system.
Future roadmap
Use cases
Who it helps, and how.
QA specialistDraft a deviation summary
Start from structured context instead of a blank page.
Process ownerRevise an SOP
See which requirements each section addresses.
Regulatory affairsPrepare a response
Organise arguments and references for a health authority question.
Human oversight
ReguWrite AI produces drafts. Authors and qualified reviewers remain responsible for content, accuracy and approval. A draft is not a controlled document until it is approved in your document system.
Related modules
Works well with
Want to see it with your own workflows?
Request a demo or join the pilot programme.