At FicusRealtime, we deliver strategic Risk Assessment and Management services to help organizations identify, evaluate, and control potential risks before they impact quality, safety, or compliance. Our approach follows international standards like ICH Q9, ISO 31000, and GAMP 5, ensuring that your processes and systems remain robust and audit-ready.
At FicusRealtime, we provide end-to-end support in responding to regulatory audit findings and ensuring full compliance with industry standards. Our expert team works closely with your Quality and Compliance departments to help you address observations, implement corrective actions, and prepare for successful re-audits.
Risk Identification & Analysis:
We work with your cross-functional teams to identify risks in manufacturing, quality systems, IT infrastructure, equipment, and third-party vendors.
Risk Evaluation:
We use proven tools such as FMEA, Risk Ranking & Filtering, and Hazard Analysis to evaluate the severity, probability, and detectability of each risk.
Risk Control & Mitigation:
Our experts design effective risk mitigation strategies that reduce impact, enhance process control, and align with regulatory expectations.
Risk Monitoring & Review:
We support ongoing risk reviews, updates to risk registers, and integration of risk management into your Change Control, CAPA, and Validation processes.
Industry-Specific Software for Enhanced Quality and Compliance
Testimonials
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
NSJ PRAYOG LIFE SCIENCES PVT.LTD
