Pass Your Next FDA Audit
with Zero Observations

We design, validate & upgrade your pharmaceutical systems so you can focus on production—not paperwork.

Explore Services
98% first-time audit pass rate

Solutions Built for Pharma 4.0

From concept to completion, our experts cover every phase of your manufacturing lifecycle.

Plant Design & Management

End-to-end solutions for green-field design, retrofit planning, and regulatory-compliant facility start-up.

Comprehensive CSV & 21 CFR Part 11 Compliance

Lifecycle validation, risk-based testing, audit prep, and ongoing support—delivered by seasoned CSV engineers.

Regulatory & FDA Audit Preparation

Mock audits, gap assessments, documentation remediation, and real-time support during regulatory inspections.

PLC & SCADA System Upgrades

Modernize legacy PLC/HMI infrastructure to GAMP 5-compliant SCADA platforms (Siemens, Allen-Bradley, Ignition). Includes design, migration, electronic signatures, data integrity, and seamless IPC deployment for pharmaceutical equipment.

Software Development

AI-enabled applications for paperless validation, audit trail capture, and real-time analytics.

Pharma 4.0 Machine Design

IoT-ready smart equipment integrating predictive maintenance and continuous process verification.

Our 3-Step Compliance Blueprint

1

Access

Free on-site or virtual audit-readiness review.

2

Implement

Rapid execution of validation, upgrades, and documentation.

3

Support

Real-time monitoring & audit rehearsal until the certificate is in your hands.

Client Success Stories

“Medicing Enterprises upgraded our SCADA & cleared our FDA audit with zero 483s in just six weeks.” — QA Director, XYZ Pharma
“Their CSV automation slashed our documentation time by 70% and paid for itself before validation wrapped up.” — Head of Engineering, ABC Labs

Get in Touch

📞 +91 91771 68899
✉️ info@medicingenterprises.com
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