Our Mission
Bring artificial intelligence into your GMP operations, validated to withstand regulatory scrutiny.
Cascade Sunrise helps life science companies deploy AI in regulated environments, backed by 15 years of quality and validation expertise. We implement the technology, validate it to current ISPE guidance, and build the quality systems and facility validation that support it.
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Artificial Intelligence
Deploy AI in your GMP environment without compromising compliance or data integrity.
- Hands-on experience implementing local and cloud-based AI solutions in GMP-regulated operations.
- Validation aligned to the ISPE GAMP® Guide: Artificial Intelligence (2025) and GAMP 5 (Second Edition).
- Practical AI implementation across a range of GMP use cases, from document generation to data analysis.
Quality System Design
Stand up an audit-ready quality system on a foundation that scales.
- Comprehensive, lean quality systems developed for GMP startup companies.
- A full suite of policies and SOPs designed to satisfy regulatory audits.
- Documentation focused on what matters: the detail regulators require, without the bloat that bogs your team down.
Startup Facility and Utilities Validation
Bring your facility online qualified, documented, and inspection-ready.
- Qualification of GMP facilities across a wide range of applications.
- Consultation on your existing documentation, or generation of complete validation packages from the ground up.
- Grounded in cGMP requirements and current ISPE guidance.
Evolving Quality Systems
Keep your quality system current as your business and the regulations change.
- Gap assessments of existing systems against regulatory requirements and industry best practice.
- Develop new procedures to match changing business needs.
- Deviation and CAPA management that keeps you compliant internally and with regulators.
About
Where AI Capability Meets GMP Discipline
Most AI specialists don’t understand GMP. Most GMP specialists don’t understand AI. Cascade Sunrise is built on both.
We pair 15 years of hands-on GMP experience across pharma, biotech, and diagnostics with practical experience deploying and validating AI in regulated environments. We’ve built three quality systems from the ground up and qualified three facilities for inspection, so the AI we implement rests on a foundation that holds up when auditors arrive.
Contact
Tell us about your project
Fill out the form and we’ll be in touch.
Prefer email? Reach us directly at chase@cascadesunrise.consulting.
Based in Bend, Oregon.