We offer end-to-end validation for GxP systems, covering planning, testing, qualification, and periodic review. Our services ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485, delivering reliable and compliant solutions for laboratory, manufacturing, and ERP systems.
We ensure compliance with FDA 21 CFR Part 11 for electronic records and signatures, EU Annex 11 for computerized systems in pharmaceutical operations, GAMP 5 for risk-based system validation, and ISO 13485 for quality management in medical devices.
We deliver key documentation including Validation Master Plans (VMP), Risk Management Reports, Traceability Matrices for full lifecycle traceability, and Periodic Review and Audit Reports to ensure compliance and robust system oversight.
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20K+ Satisfied Clients World Wide
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
Mangalam Organics Limited
VINS BIOPRODUCTS LIMITED
ORCH Laboratories India Pvt.Ltd
Extrovis Private Limited
ISO Quality Management System