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The GxP Execution System.
Start in development. Scale to production. Reach patients faster.
Development (Non-GxP)
$3,000
per system / month
Unlimited users & storage
Full Platform (MES, QMS, LIMS, ELN)
21 CFR Part 11 compliant
SSO & SAML
Client & partner portals
Full implementation & data migration
Equipment & software integrations
Onsite training & go-live support
AI writes your documents
AI builds templates and workflows
AI finds gaps before auditors do
AI answers your questions
5-minute support response
Production (GxP)
$5,000
per system / month
Everything in Development
Automated continuous validation (No manual IQ/OQ)
One-click audit packets
Automated APR/PQR generation
Need a system per project (CDMO)? Early-stage startup?
Ask about custom pricing →
How many users can I have?
Unlimited. Add employees, auditors, inspectors, clients, partners. No per-seat fees, ever.
What's included?
Everything. QMS, ELN, LIMS, MES, design controls, regulatory submissions. All blueprints, all AI features, no extra charge.
What compliance frameworks do you support?
All of them. GLP, GMP, GCP, GDP, ISO 13485, ISO 9001, 21 CFR Part 11, Annex 11.
What does GxP Validation include?
Automated continuous validation. No manual IQ/OQ/PQ. One-click audit packets. Automated APR/PQR generation. Everything you need to stay audit-ready.
How long to go live?
The platform is ready in 48 hours. Full migration depends on your data volume, but our AI tools typically compress months of work into days.
What about our existing data?
We migrate it. PDFs, spreadsheets, legacy systems. We've seen it all.
Can I export my data?
Yes. Full export anytime, standard formats. No lock-in.
When do I need multiple systems?
When teams need separate access controls. One system handles everything until then.
Go live in 48 hours.
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