NEWSROOM

Solutions for Cell & gene Therapy

Accelerate Readiness and Reliability in Cell & Gene Therapy

Scale GMP operations fast—with compliant, configurable asset management.

Cell and gene therapy innovators face intense pressure to scale production while maintaining tight regulatory control. Blue Mountain RAM is the life sciences CMMS/EAM platform that meets this challenge. With embedded calibration, maintenance, and asset management, RAM helps CGT teams digitize operations, enforce compliance, and scale.

Speed and Compliance in a High-Stakes Environment

Cell and gene therapy manufacturers must balance cutting-edge innovation with strict GMP expectations—and do it fast.

Ramp up new sites while ensuring calibration and maintenance compliance

Standardize asset workflows despite novel equipment and fast-changing needs

Maintain data integrity and electronic traceability across teams

Scale operations with confidence under increasing regulatory scrutiny

Purpose-Built for Fast-Moving, Regulated Environments

Blue Mountain RAM supports rapid CGT scale-up while protecting compliance and quality—on a single, validated platform.

Ready for Rapid Scale

  • Templates and best practices accelerate site startup
  • Supports new modalities and hybrid equipment types
  • Cloud-native delivery means no IT delay

GMP-First Functionality

  • Validated workflows with 21 CFR Part 11 compliance
  • Full audit trails, electronic signatures, and Non-Conformance tracking
  • Designed to support EMA and FDA inspection readiness

Integrated Calibration and Maintenance

  • Automate PM and calibration for unique CGT instruments
  • Mobile-ready execution ensures floor-level visibility
  • Multi-language and multi-site support for global growth

Data-Driven Performance

  • Near real-time dashboards for asset reliability and calibration status
  • Out-of-tolerance alerts, root cause support, and KPI reporting
  • Integrates with MES, QMS, and other digital systems

Leading Life Sciences Organizations Trust Blue Mountain

Ready to Protect Every Batch You Cannot Repeat