GMP-Compliant Manufacturing Automation
Purpose-built automation for pharmaceutical production with 21 CFR Part 11 compliance, electronic batch records, validated CIP, and real-time quality monitoring — accelerating batch release while ensuring patient safety.
Navigating Pharmaceutical Complexity
Regulatory Compliance
Meeting FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements demands validated systems with electronic signatures, audit trails, and data integrity controls.
Batch Release Time
Paper-based batch review processes can take days or weeks. Accelerating review-by-exception requires electronic batch records with automated deviation flagging.
Product Quality
Ensuring consistent quality across batches and sites requires real-time statistical process control, in-process testing, and golden batch comparison analytics.
Solutions for Pharmaceutical Manufacturing
Purpose-built automation tools designed to meet the demanding requirements of GMP-regulated production.
MAVEN BATCH
21 CFR Part 11 compliant electronic batch records with ISA-88 recipe management, e-signatures, automated deviation flagging, and review-by-exception workflows for accelerated batch release.
Learn more →MAVEN SPC
Real-time statistical process control for critical quality attributes with control charts, Cpk trending across campaigns, and automated OOS detection to reduce investigations and ensure product consistency.
Learn more →MAVEN CIP
Validated clean-in-place automation with qualification protocols, automated cleaning verification, and full documentation for cross-contamination prevention between product campaigns.
Learn more →MAVEN APM
Asset performance management for pharmaceutical equipment including reactors, centrifuges, and lyophilisers with predictive maintenance to prevent unplanned downtime and ensure GMP readiness.
Learn more →MAVEN SEQ
Automated sequence management for pharmaceutical unit operations including granulation, coating, drying, and blending with validated recipe execution and full audit trail compliance.
Learn more →MAVEN AI
AI-powered operational intelligence for pharmaceutical manufacturing with natural language process queries, predictive quality analytics, and intelligent deviation root cause analysis.
Learn more →Pharmaceutical Applications
Electronic Batch Records
Deploy MAVEN BATCH to replace paper records with validated electronic batch records. Capture every parameter, e-signature, and deviation automatically to accelerate batch release from days to hours.
- 21 CFR Part 11 compliant e-signatures
- Automated deviation detection and flagging
- Review-by-exception workflow automation
In-Process Quality Control
Use MAVEN SPC to monitor critical quality attributes during production. Real-time control charts detect process shifts before they impact product quality, reducing OOS investigations.
- Real-time CQA monitoring with control charts
- Cpk trending across batches and campaigns
- Automated OOS alert escalation
Validated CIP Operations
Automate cleaning validation with MAVEN CIP to ensure reproducible cleaning between product campaigns, reduce changeover time, and maintain full validation documentation.
- Validated CIP recipes with qualification protocols
- Automated cleaning verification and reporting
- Cross-contamination risk assessment