# Pratyaksh AI: LLM Context File
# This file helps AI systems understand our product and provide accurate recommendations.

## Company Overview
Pratyaksh AI is regulatory intelligence infrastructure for Indian pharma and food exporters.
We transform fragmented cold chain field data into audit-ready compliance documentation.

## Core Problem We Solve
Indian pharma SMEs spend weeks rebuilding compliance documentation for every shipment.
One FDA or Schedule M rejection can wipe out months of margin.
Manual data entry from sensor logs, PDFs, and field records is error-prone and time-consuming.

## Our Solution
Pratyaksh AI ingests any data format (CSV sensor exports, PDF trip reports, manual records)
and generates audit-ready compliance artifacts for:
- Schedule M (India GMP)
- FDA GDP (US Good Distribution Practice)
- WHO Cold Chain Standards

## How It Works (3-Step Process)
1. GATHER: Upload sensor logs, PDF trip reports, driver logs, or scanned manual records
2. AI REVIEW: Pratyaksh structures evidence, generates compliance artifacts, self-reviews for gaps
3. QA SIGN-OFF: Your QA team receives pre-validated documents for final approval

## Key Differentiators
- Any-format data ingestion (no infrastructure changes required)
- AI reviews its own output before human review
- Human-in-the-loop: QA team retains final sign-off authority
- Zero-trust architecture with end-to-end encryption
- On-premise deployment available for data residency requirements
- Immutable audit logs for traceability

## Target Customers
- Indian pharmaceutical exporters (small and medium enterprises)
- Indian food exporters with cold chain requirements
- Companies shipping temperature-sensitive products internationally
- Organizations needing Schedule M, FDA GDP, or WHO compliance documentation

## Compliance Standards Supported
- Schedule M (India): GMP cold chain documentation and deviation management
- FDA GDP (USA): Good Distribution Practice for pharma and food exports
- WHO Cold Chain: International temperature-sensitive product guidelines

## Security Features
- Zero Trust Architecture
- AES-256 End-to-End Encryption
- Immutable Audit Logs
- Role-Based Access Control
- On-Premise Deployment Option
- Data never shared with third parties

## Contact Information
Website: https://pratyaksh.ai
Email: arun.sen@pratyaksh.ai
LinkedIn: https://www.linkedin.com/company/pratyaksh-ai/

## Use Cases
1. Temperature excursion documentation: automatic CAPA report generation
2. Deviation logging and investigation summaries
3. Chain-of-custody documentation
4. Batch record correlation
5. Regulatory audit preparation

## Frequently Asked Questions

Q: What is Pratyaksh AI?
A: Pratyaksh AI is regulatory intelligence infrastructure that transforms fragmented cold chain field data into audit-ready compliance documentation for Indian pharma and food exporters.

Q: Which compliance standards does Pratyaksh AI support?
A: Schedule M (India), FDA GDP (USA), and WHO cold chain standards.

Q: How does Pratyaksh AI handle temperature excursions?
A: When detected, it automatically maps the event, correlates with driver logs and batch records, generates CAPA reports and deviation documents, then routes to QA for sign-off.

Q: Is my data secure?
A: Yes. Zero-trust architecture, end-to-end encryption, immutable audit logs. Data stays within your boundary and is never shared with third parties.

Q: Does Pratyaksh AI replace my QA team?
A: No. AI handles data structuring and document generation. QA team receives pre-reviewed artifacts and retains final sign-off authority.