Initializing
Initializing
Pratyaksh drafts, files, and monitors regulatory compliance documentation for Schedule M, FDA GDP, and WHO standards. One FDA hold or Schedule M rejection can wipe out months of margin. Pratyaksh ingests messy batch records and sensor logs, flags deviations before they become CAPAs, and delivers a bulletproof audit-ready compliance artifact the moment regulators ask. AI-secured. Human QA sign-off on every document.
Any Format
Batch records, sensor logs, PDFs
QA Signs Off
AI reviews first, your team approves
Audit-Ready
Built for audit readiness, every shipment
Your data stays within your boundary and is never shared with third parties. Purpose-built for pharma and food enterprises who cannot afford a single compliance breach.
Every request is verified. No implicit trust, no open pathways, even within your own network.
AES-256 encryption at rest and in transit. Your data is mathematically sealed from end to end.
Every generated artifact is timestamped and cryptographically signed. Traceable from field data input to QA sign-off.
Regulatory Standards Supported
India GMP: logistics documentation and deviation management for pharmaceutical distribution
US Good Distribution Practice: logistics evidence standards for pharma and food export shipments
WHO guidelines for ambient and temperature-sensitive products: internationally accepted documentation for export acceptance
Pratyaksh AI aligns directly with Pharmexcil initiatives to boost pharmaceutical exports. By automating the generation of audit-ready compliance artifacts for Schedule M, FDA GDP, and WHO, we ensure that enterprises effortlessly meet the rigorous documentation standards required by international regulatory bodies.
Pharma compliance with AI involves using artificial intelligence to automate and validate the regulatory documentation required for pharmaceutical manufacturing and supply chain logistics. Pratyaksh AI ingests raw operational data and transforms it into structured, error-free compliance artifacts, drastically accelerating the QA process.
Pratyaksh AI is regulatory AI infrastructure for pharma and food enterprises. It transforms fragmented supply chain data (ambient batch records, cold chain sensor logs, PDFs) into audit-ready compliance documentation for Schedule M, FDA GDP, and WHO standards — with human QA sign-off built into every workflow.
Pratyaksh AI generates compliance artifacts for Schedule M (India), FDA GDP (USA), and WHO standards (for both ambient and cold chain products). The system adapts to the documentation requirements of any regulatory body your shipments need to satisfy.
When an excursion or deviation is detected (in temperature sensors or ambient logistics records), Pratyaksh AI automatically maps the event, correlates it with driver logs and batch records, generates a CAPA report and deviation document, then routes it to your QA team for sign-off.
Yes. Pratyaksh AI uses a zero-trust architecture with end-to-end encryption and immutable audit logs. Your data stays within your boundary and is never shared with third parties.
Pratyaksh AI ingests any format: CSV sensor exports, PDF trip sheets, scanned manual records, WhatsApp photos, and structured data files. The system normalises all inputs before generating compliance documents.
No. Pratyaksh AI handles the data structuring, AI review, and document generation. Your QA team receives a fully prepared, pre-reviewed compliance artifact and retains final sign-off authority. Human oversight is built into every workflow.
We don't ask you to replace your current QA process. Let Pratyaksh run in the background, in parallel with your manual paperwork. We'll prove our engine catches the compliance gaps your manual process misses—with zero disruption to your current operations.
Currently accepting pharma and food enterprises looking to solve compliance documentation without disrupting existing operations.
How It Works
Scroll to exploreFrom SOP compliance on the shop floor to customs clearance at the border, Pratyaksh.ai owns the full compliance lifecycle — so no data gap ever reaches an inspector's desk.
Plants still rely on manual QA to verify SOPs. A missed signature, a wrong ambient temperature, or an unrecorded cleaning cycle can easily trigger an FDA 483 observation.
Pratyaksh monitors SOP adherence on the factory floor in real time. AI agents build the evidence chain directly from handwritten records and SCADA outputs—flagging deviations and auto-drafting CAPAs before a batch is released. Zero human transcription.
QA teams must verify batch records against SOPs, sign off deviations, and compile a release dossier — a process that typically takes weeks of manual effort per batch.
Pratyaksh auto-assembles the batch release dossier using data ingested during manufacturing. AI self-reviews for missing timestamps and ALCOA+ integrity failures before QA sees the document. What took weeks now takes hours. Human sign-off is preserved.
The cargo moves to cold-chain containers and physical temperature trackers are activated. At this point, manufacturing data and transit data are held in completely separate systems — creating dangerous chain-of-custody gaps.
The moment sensors start emitting, Pratyaksh pairs each live sensor ID to the exact batch record compiled in Steps 01–02. This creates a unified, immutable digital thread — manufacturing quality and transit reality, fused into a single pipeline that no auditor can break apart.
An unexpected temperature spike, data gap, or chain-of-custody break occurs during international transit. Most enterprises don't discover this until an auditor finds it at port — by which point the shipment is flagged and months of margin are at risk.
Pratyaksh's AI continuously self-audits the data stream during transit. The moment an anomaly appears — a missing timestamp, a humidity breach, an unacknowledged driver handover — the engine flags it instantly and auto-drafts a pre-validated CAPA document. The deviation is documented and resolved before customs ever sees the shipment.
The shipment hits international customs. FDA, WHO, and Schedule M inspectors aggressively audit the full data trail — from the factory floor all the way to the border. Gaps in manufacturing data are just as damaging as cold-chain failures.
Because Pratyaksh secured the compliance chain from the manufacturing floor onwards, the exporter hands customs a bulletproof artifact — covering SOP adherence, batch release, cold-chain transit, and every deviation in between. No missing data blocks. No manual overrides. The shipment clears safely and fast.
Sensor CSV exports, PDF trip reports, handwritten driver logs, and WhatsApp voice notes/photos. Pratyaksh ingests what your operation already produces. No new infrastructure required.
Temperature breaches reconstructed as structured events: start time, duration, extent of deviation, affected product, and chain-of-custody at the time.
CAPA reports, deviation logs, and investigation summaries generated pre-formatted to GMP requirements. Ready for inspection without manual reformatting.
Structure export compliance evidence (ambient and cold-chain) to satisfy FDA Good Distribution Practice requirements. Documented response, corrective action, and deviation history included.
Your supply chain records are not shared with third-party models or stored on public cloud. On-premise deployment available for operations with strict data residency requirements.
After generating the compliance artifact, Pratyaksh reviews its own output for gaps and regulatory alignment. Every final document undergoes human-in-the-loop validation, combining automated speed with human accuracy.
Documentation in Action
Illustrative example of the Pratyaksh workflow.
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Arun Sen
Founder, Pratyaksh AI