Automated 21 CFR Part 11 & Risk-Based Quality Management
Modern Life Science organizations face unprecedented complexity in maintaining compliance and managing risk across global, multimodal operations.
Shifting focus to RBQM, requiring continuous validation rather than one-time installs.
Reliance on manual "checklist" compliance leads to human error, subjectivity, and significant operational bottlenecks.
Our Agentic AI solution acts as a Continuous Validation Engine, automating the reconciliation of data across HPLC, LC-MS, and e-Binders. By treating the system as a "Validation Layer," we ensure 21 CFR Part 11 compliance through automated audit trails, signature verification, and evidence report generation.
Auto-Accuracy
Traceability
GxP Ready
Shift from manual spot-checks to 100% data oversight.
Automated Evidence Reports reduce QA review time by 70%.
Eliminate "Information Chaos" across fragmented legacy systems and data silos such as Quickbase & Watson.
Automated mapping of regulatory requirements to internal SOPs and data structures.
Continuous audit agents identify outliers and protocol violations, fulfilling Risk-Based Quality Management requirements.
AI-driven identification of compliance gaps between current data states and regulatory benchmarks.
Dynamic risk scoring with full audit trails, providing a clear "why" behind every compliance metric.
Ingesting exports from HPLC, LC-MS, and other data silos for initial verification.
Agents perform automated reconciliation by verifying data and calculating sample counts against rules.
Standardized Evidence Reports document the rigorous check and any discrepancies found.
Final data and Evidence Reports are pushed into a 21 CFR Part 11 compliant environment.
Human reviewers perform final validation of the agent-generated Evidence Report.
Formal electronic signatures are applied to the validated report for regulatory submission.
Full audit trails and secure electronic signatures for all validation actions.
Risk-Based Quality Management integrated into the agentic workflow.
ALCOA++ standards enforced from acquisition to reporting.
Role-based access and encrypted storage in validated environments.