Compress Validation Cycles from Months to Days
KarmaSatya's AI engine generates IQ, OQ, and PQ protocols tailored to your specific systems and regulatory environment. Intelligent gap analysis identifies missing evidence before it becomes a finding. Real-time execution tracking ensures every test step is documented, timestamped, and traceable.
- Auto-generated IQ/OQ/PQ test scripts from system specifications
- Intelligent gap analysis against regulatory requirements
- Real-time protocol execution with automated evidence capture
- Deviation management with AI-assisted root cause analysis
- Validation summary reports generated automatically
AI Validation Automation
Stay Ahead of Evolving Regulatory Requirements
Continuous monitoring of your compliance posture against FDA, EMA, ICH, and ISO frameworks. KarmaSatya maps your processes to current regulatory requirements, flags gaps in real time, and provides actionable remediation guidance — so you're always inspection-ready, not just audit-prepared.
- Automated regulatory requirement mapping and traceability
- Real-time compliance posture dashboard across all systems
- Regulatory change monitoring with impact assessment
- Remediation workflow with prioritized action items
- Multi-framework support: FDA, EMA, ICH, ISO, EU Annex 11
Regulatory Compliance Management
Immutable Records. Inspection-Ready Packages.
Every validation activity in KarmaSatya generates a complete, immutable audit trail — timestamped, user-attributed, and tamper-evident. Automated documentation packages compile all evidence, test results, and approvals into inspection-ready formats that satisfy FDA, EMA, and notified body reviewers.
- Immutable, 21 CFR Part 11-compliant electronic records
- Automated compilation of validation documentation packages
- Electronic signature workflows with full audit trail
- Version-controlled document management with change history
- One-click export in regulator-preferred formats
Audit Trail & Documentation
Identify Validation Gaps Before They Become Findings
KarmaSatya's risk intelligence engine continuously analyzes your validation landscape, identifying gaps, anomalies, and emerging risks before they surface in an inspection. AI-driven risk scoring prioritizes remediation efforts so your team focuses on what matters most.
- AI-driven risk scoring across all validated systems
- Proactive gap identification with remediation recommendations
- Risk-based validation approach aligned with GAMP 5
- Continuous monitoring with configurable alert thresholds
- Risk trend analysis and executive reporting dashboards
Risk Intelligence
See KarmaSatya in Action
Schedule a personalized demo and discover how AI-powered validation can transform your compliance operations.