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
✓ 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
💧 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
📡 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
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
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