AI-assisted controlled documents for regulated science
SIMS gives pharma and biotech teams a GMP-grade controlled-document workspace where AI agents draft alongside your scientists — versioning, review workflows, electronic signoff, and a complete audit trail built in.
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A documents workspace built for quality
Everything your controlled documents need — from first AI-assisted draft to signed, audit-ready record.
Controlled document management
Organize SOPs, protocols, specifications, and reports in a document tree with a filing taxonomy — document types, departments, folders — that you configure per workspace.
Review & approval workflows
Named workflow templates with explicit states move every document through drafting, review, and approval the same way, every time.
Electronic signoff
Capture internal approvals on a signoff timeline — and collect client signatures through secure one-time links, no account needed on their side.
Versioning & section-level review
Full version history with side-by-side diffs. Review edits patch by patch: accept, reject, or undo individual sections.
AI-assisted drafting
Every document has a durable collaboration channel where AI agents draft live, take structured asks, and make targeted section edits — multiple bots, streaming, in context.
Roles & collaboration
Authors, collaborators, reviewers, and observers with managed permissions, live presence, and retained human comments.
Complete audit trail
Every access and change is logged. Lifecycle evidence is retained and exportable as sealed workflow bundles — built for GMP expectations.
Self-service workspaces
Sign up, verify your email, invite your team, and manage roles yourself. Your workspace is live in minutes.
Run SIMS on your own infrastructure
The full SIMS platform is available on-prem — including SIMS Quality Control, a LIMS workspace for regulated laboratory operations, alongside the same documents, signatures, and audit platform services.
Contact us about on-prem- Work orders & analysis requisitions
- Certificates of analysis
- Stability programs & timepoints
- Sample storage & product specifications
- Projects, quotations & invoicing
- Client portal collaboration
Register interest
Want a demo, early access for your team, or the on-prem solution? Leave your details and we'll get back to you.