We deliver a rigorous and systematic qualification process. It covers user requirement specification, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
We ensure your facility, equipment, and systems that exceed global GMP standards. Our domain experts assess each critical component, from cleanroom environments to production utilities, verifying installation integrity, functionality, and design compliance with meticulous attention to detail.
Our validation strategies are customized to your processes and regulatory landscape. We incorporate both traditional and continuous process validation. We establish robust protocols that define critical parameters and acceptance criteria with real-time analytics throughout the lifecycle of your product.
Development of Qualification Protocols for Equipment & Automation.
Development of DQ, IQ, OQ and PQ Documents.
Standard Operation Procedures (SOP) for Process and Quality Control.
Factory Acceptance Test.
Site Acceptance Test.
Equipment Validation.
Utility and Facility Validation.
Computer System Validation.
PLC HMI & Automation Validation.
Review and Develop User Requirement Specification (URS)
Review of Functional Design Specification (FDS) of equipment.
Qualification Schedule.
Validation Master Plan (VMP).
Risk & Impact Assessment.
Shaped Coca Cola’s world-class FBC ASSP bottling facility with master planning to detailed engineering, meeting WHO and FSSAI benchmarks.
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