Pharmaceuticals

Compliance-Ready Traceability

The Challenge

Pharmaceutical manufacturing demands the highest standards of traceability, compliance, and quality control. From raw material qualification to batch tracking through production to finished goods dispatch—every step must be documented with audit-proof records.

  • Regulatory compliance with GMP, FDA, WHO, and other standards requiring complete traceability
  • Clean room asset tracking for environmental monitoring equipment without contamination risk
  • Batch traceability from raw materials to finished goods with complete chain of custody
  • Temperature monitoring for cold chain and controlled storage areas
  • Equipment calibration tracking and preventive maintenance for critical instruments
  • Audit trails that are immutable and provide complete transparency for inspections

Manual paper-based systems create gaps in documentation. Non-compliant tracking risks recalls and regulatory action. IoTReady provides audit-proof digital traceability that meets the strictest regulatory requirements.

How IoTReady Helps Pharmaceutical Manufacturing

Compliance-ready solutions for batch traceability, asset tracking, and environmental monitoring

Raw Material to Finished Goods Traceability

Complete batch tracking from raw material receipt through formulation, packaging, and dispatch. Digital chain of custody with timestamps and operator authentication.

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Asset Tracking in Clean Rooms

Track environmental monitoring equipment, calibrated instruments, and critical assets within clean room environments. Clean room compatible hardware.

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Cold Chain Monitoring

24/7 temperature and humidity monitoring for cold storage, refrigerators, and controlled environments. Instant alerts for excursions with complete audit trails.

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Inventory Audit (PI/PV) Automation

Conduct cycle counts quickly with RFID or barcode scanning. Real-time reconciliation with ERP. Audit-proof inventory records for regulatory inspections.

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Productivity Monitoring

Track operator activities and ensure SOP compliance throughout production. Digital checklists and workflow validation prevent deviations.

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Predictive Maintenance

Track equipment calibration schedules, maintenance history, and instrument qualifications. Ensure critical equipment is always qualified and operational.

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Sterilisation Process Management

Paperless workflows for gamma irradiation, ETO, E-beam, and steam sterilisation. QR tracking, automated weighment, and certificate generation.

See Microtrol Case Study →

Customer Success: Microtrol India

Paperless workflow for gamma irradiation sterilisation

Microtrol India provides sterilisation services including Gamma Radiation, Ethyl Oxide, Electron Beam, and Steam Sterilisation to pharmaceutical and medical device manufacturers. Their gamma irradiation plant handles 600 boxes per day in 24x7 operations.

IoTReady implemented a comprehensive paperless workflow solution with QR code tracking, automated weighment, mobile tablets for operators, and Tally integration. The system replaced 9+ paper documents per consignment with digital workflows.

Business Impact

  • 90% reduction in paper usage
  • Zero manual weight recording errors
  • Real-time consignment visibility 24x7
  • Instant document retrieval for audits
  • 50% faster billing cycle

Technologies

  • QR code batch tracking
  • Rugged tablets (Chainway P80)
  • Automated weighment integration
  • Tally ERP integration
  • Digital forms and certificates

Read Full Case Study →

Built for Pharmaceutical Compliance

Audit-Proof Records

Immutable digital records with timestamps, operator authentication, and complete chain of custody. Every transaction logged and traceable.

GMP Compliant

System designed to support Good Manufacturing Practice requirements. Electronic batch records with full traceability.

21 CFR Part 11 Ready

Electronic signatures, access controls, and audit trails meet FDA electronic records requirements.

Serialization Support

Track individual unit serialization from production through distribution. Support for GS1 standards and regulatory serialization mandates.

Deviation Management

Automatic alerts for temperature excursions, SOP violations, and other deviations. Complete investigation records.

Change Control

Version-controlled business rules and workflows. Complete change history for all system configurations.

Business Impact for Pharmaceutical Manufacturing

100%

Audit Trail Completeness

Every transaction documented

Zero

Manual Errors

Automated data capture

Real-Time

Compliance Monitoring

Instant deviation alerts

Minutes

Recall Response Time

vs. days with manual records

Why Pharmaceutical Companies Choose IoTReady

Clean Room Compatible

Hardware designed for controlled environments. No contamination risk from tracking equipment.

Regulatory Expertise

System designed by engineers who understand pharmaceutical compliance requirements and GMP principles.

Validation Support

Documentation and support for IQ/OQ/PQ validation protocols. Change control and version management.

Immutable Records

Blockchain-backed audit trails ensure records cannot be altered retroactively. Complete data integrity.

Electronic Signatures

21 CFR Part 11 compliant electronic signatures with operator authentication and approval workflows.

Rapid Deployment

Configurable workflows adapt to your SOPs without extensive custom development. Deploy in weeks, not years.

Ready for Audit-Proof Traceability?

See how we help pharmaceutical manufacturers meet the strictest compliance requirements