Life Sciences

21 CFR Part 11 SCADA Systems | Pharmaceutical Automation Solutions India | Advance Engineers

Ensure 100% Data Integrity with USFDA Compliant Automation Systems

Bridge the gap between field instrumentation and digital compliance

Deploy GMP-grade automation that turns regulatory pressure into competitive advantage

📋 Download FREE Compliance Checklist 📞 Request a Call Back 📱 Call +91-8427001018

✓ 21 CFR Part 11 Compliant  |  ✓ USFDA Audit Ready  |  ✓ Complete IQ/OQ/PQ Support

Stop Gambling with Audit Outcomes

Every manual log entry is a risk. Every unvalidated instrument is a potential deviation. Pharmaceutical manufacturers face relentless scrutiny.

❌ Failed USFDA Audits

Data integrity gaps and missing audit trails lead to warning letters, compliance issues, and expensive remediation projects.

❌ Manual Data Logging

Human errors compromise batch documentation and traceability requirements, putting product quality at risk.

❌ Inaccurate Measurement

Flow and dosing errors lead to OOS (Out of Specification) results and costly batch rejections.

The Advance Engineers Difference

We architect compliance ecosystems. Our pharmaceutical automation solutions eliminate human error, create tamper-proof audit trails, and transform critical process parameters into real-time, validated digital records.

We automate your compliance so you can focus on production.

Pharma-Grade Instrumentation Built for Regulatory Excellence

🖥️ 21 CFR Part 11 Compliant SCADA & Dashboards

Move beyond paper-based batch records. Our pharmaceutical SCADA systems deliver complete electronic record and signature compliance:

  • Electronic Signatures: Role-based access control with Active Directory integration
  • Complete Audit Trails: Captures "Who, What, When, Why" for every data point and user action
  • Secure Data Archiving: Encrypted SQL database storage with backup protocols
  • Real-time Alerting: Immediate notifications for out-of-specification conditions
  • Validation Support: Full IQ/OQ/PQ documentation package included
Applications: WFI generation systems, fermentation control, sterile filling line supervision, environmental monitoring, clean room pressure mapping
Request SCADA Demo

💧 High-Precision Flow Meters for Critical Applications

Accurate measurement isn't optional in pharmaceutical manufacturing. Our flow instrumentation ensures dosing accuracy and regulatory compliance:

  • Coriolis & Magnetic Flow Meters: ±0.1% accuracy for critical dosing applications
  • Sanitary Designs: 3A and EHEDG certified with hygienic tri-clamp fittings
  • Material Traceability: Full mill certificates and material test reports provided
  • Calibration Certificates: NABL/ISO 17025 traceable calibration included
  • Validation Documentation: Factory Acceptance Test (FAT) reports available
Applications: WFI (Water for Injection) systems, API dosing, solvent metering, buffer preparation, CIP/SIP flow verification
Get Flow Meter Quote

📡 Clean Room Monitoring & Level Sensors

Maintain process integrity in sterile and controlled environments with validated sensing solutions:

  • Non-Contact Radar Level: Contamination-free measurement for tanks and vessels
  • Differential Pressure: Clean room classification monitoring and airlock status
  • Flush Diaphragm Pressure: Hygienic pressure measurement with zero dead volume
  • Temperature Sensors: RTDs and thermocouples with sanitary connections
  • Vibration Monitoring: Predictive maintenance for pumps and rotating equipment
Applications: Clean room pressure cascades, bioreactor level control, buffer tank monitoring, HVAC validation, equipment health monitoring
View Sensor Specifications
📋

Is Your Facility 21 CFR Part 11 Ready?

Don't wait for a warning letter. Download our comprehensive compliance readiness checklist developed by experienced automation engineers who understand FDA expectations.

Your FREE Checklist Includes:

  • Electronic Record & Signature Assessment
  • Audit Trail Completeness Verification
  • User Access Control & Password Policy Review
  • Data Backup & Recovery Procedures Evaluation
  • System Validation Status Check
  • Vendor Qualification Requirements
📥 Download Your FREE Checklist Now

No credit card required. Instant PDF download. Used by 500+ pharma facilities.

Ready to Achieve FDA Compliance?

Let's discuss your specific requirements. Our team of automation engineers is ready to help with technical specifications, quotations, and validation support.

Request Technical Consultation 📞 Call Now: +91-8427001018

This website uses cookies.