The Process
From Assessment to
Certification.
KarmaSatya follows a structured, four-phase methodology that transforms your validation landscape — systematically, transparently, and with full regulatory traceability at every step.
Assess
Understand before you act.
Every successful validation program begins with a clear picture of where you stand. KarmaSatya's AI-powered assessment engine analyzes your systems, processes, and existing documentation to establish a comprehensive validation baseline.
We map your current validated systems against applicable regulatory frameworks — FDA 21 CFR Part 11, GAMP 5, ISO 13485, EU Annex 11 — and generate a prioritized gap report. No assumptions. No guesswork. Just a precise, evidence-based starting point.
Phase Outputs
- System inventory and classification report
- Regulatory gap analysis with risk scoring
- Validation scope and boundary definition
- Prioritized remediation roadmap
Assess
Understand before you act.
Configure
Tailored to your environment.
No two regulated organizations are identical. KarmaSatya's configuration layer adapts the platform to your specific regulatory environment, organizational structure, and risk tolerance — without custom development.
Define your validation frameworks, configure risk thresholds, establish approval workflows, and set up your organizational hierarchy. KarmaSatya's intelligent defaults accelerate setup while giving your team full control over every compliance parameter.
Phase Outputs
- Configured validation protocol templates
- Regulatory framework mapping and traceability matrix
- Approval workflow and electronic signature setup
- Risk threshold and alert configuration
Configure
Tailored to your environment.
Validate
Execute with intelligence.
With protocols configured, your team executes validation activities through KarmaSatya's guided workflow engine. AI assistance surfaces anomalies, flags deviations, and ensures every test step is documented with the precision regulators expect.
Real-time execution monitoring tracks protocol progress across all active validations. Automated evidence capture eliminates manual transcription errors. Deviation management workflows ensure every non-conformance is documented, investigated, and resolved — with a complete, immutable audit trail.
Phase Outputs
- Executed IQ/OQ/PQ protocols with timestamped evidence
- Deviation and CAPA records with root cause analysis
- Real-time validation progress dashboard
- Automated anomaly detection and alert log
Validate
Execute with intelligence.
Certify
Inspection-ready, always.
When validation activities are complete, KarmaSatya automatically compiles your validation package — a complete, organized, inspection-ready documentation set that satisfies FDA, EMA, and notified body reviewers.
Validation summary reports, traceability matrices, electronic signature manifests, and audit trail exports are generated in regulator-preferred formats. Your team reviews, approves, and archives — KarmaSatya handles the rest. Every package is immutable, versioned, and retrievable in seconds.
Phase Outputs
- Complete validation summary report (VSR)
- Traceability matrix linking requirements to test evidence
- Electronic signature manifest and approval records
- Archived, immutable validation package
Certify
Inspection-ready, always.
Our Philosophy
Compliance Is Not a Checkbox
KarmaSatya is built on the belief that genuine compliance — karma and satya in practice — requires more than documentation. It requires truth.
Proactive, Not Reactive
We identify compliance risks before they become inspection findings. Our AI continuously monitors your validation landscape so you are never caught off guard.
Evidence-Based, Always
Every compliance claim in KarmaSatya is backed by traceable, immutable evidence. We do not allow assertions without proof.
Transparent by Design
Full audit trails, version histories, and change logs are not optional features — they are the foundation of how KarmaSatya works.
Continuously Improving
Regulatory requirements evolve. KarmaSatya's AI learns from new guidance, inspection trends, and industry best practices — keeping your compliance posture current.
Ready to Start Your Validation Journey?
See the full KarmaSatya methodology in action with a personalized walkthrough of your specific validation environment.