AI-powered operational intelligence for pharmaceutical, biotech, and medical device organizations navigating complex regulatory environments.
Industry Challenges
Maintaining 21 CFR Part 11, EU Annex 11, and GMP compliance requires comprehensive audit trails, validated systems, and real-time process monitoring at scale.
A single batch failure can cost millions and delay product launches by months. Early detection of process deviations is critical but difficult with legacy systems.
Transitioning from lab-scale to commercial manufacturing while maintaining quality attributes is one of the most complex challenges in the industry.
The InfoSteer Difference
Real-time monitoring with full electronic batch records, automated deviation alerts, and audit-ready documentation built to 21 CFR Part 11 standards.
ML models trained on your historical batch data predict deviation risk in real time — allowing operators to intervene before a batch fails, protecting yield and product integrity.
InfoSteer captures and codifies process knowledge, enabling faster, more reliable technology transfer from development to commercial manufacturing.
Outcomes
Reduction in batch failures through early deviation detection
Faster audit preparation with automated documentation and reporting
Electronic data integrity compliance rate across all monitored processes
Related Products
Reduced batch failure rate from 8.2% to 3.9% and cut FDA audit prep time by 65%.
Deploying PIP with validated electronic batch records and predictive analytics, this manufacturer transformed their quality management approach.
Read Case StudiesSee how InfoSteer delivers measurable results in Life Sciences. Get a personalized demo tailored to your specific use case.