Strategic Regulatory Consulting for Accelerated Global Compliance

Quality Management System Compliance

At FicusRealtime, we understand that quality isn’t just a goal—it's a requirement. Our Quality Management Compliance System (QMS) is designed to help regulated industries such as pharmaceuticals, biotech, and healthcare achieve robust quality assurance and regulatory compliance with ease.

Our QMS solution provides an end-to-end framework for managing quality processes, ensuring compliance with international standards such as ISO 9001, ICH Q10, 21 CFR Part 11, and EU GMP. Whether you're managing deviations, CAPAs, audits, or training, FicusRealtime helps you stay audit-ready and inspection-proof.

Document Control:
Centralized and secure document management with version control, electronic signatures, and audit trails.
Training & Competency Management:
Track employee qualifications, automate training workflows, and ensure skill readiness across departments.
CAPA Management:
Identify root causes, implement corrective and preventive actions, and monitor effectiveness in a structured manner.
Audit Management:
Schedule, conduct, and follow up on internal and external audits with ease.
Change Control:
Manage and track changes to processes, equipment, and documentation with complete transparency.
Deviation Management:
Capture, investigate, and resolve deviations from SOPs or GMP requirements in a timely manner.
Risk Management:
Assess and mitigate operational and compliance risks using a systematic and proactive approach.
Supplier Quality Management:
Evaluate, qualify, and continuously monitor supplier performance to ensure raw material and service quality.

 

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Pharma
Advancing healthcare through pharmaceutical innovations.
Engineering
Precision engineering solutions for industrial applications.
Excipients
Quality excipients for enhanced pharmaceutical formulations.
Formulations
Innovative drug formulations for effective treatments.
Biologicals
Advanced biological solutions for medical and research use.
Biotechnologicals
Cutting-edge biotechnological applications for various industries.
CRO/CDMO
Contract research and manufacturing for pharma industries.
Aquatic/Poultry
Innovative healthcare solutions for aquaculture and poultry.
Agro Based
Sustainable agro-based solutions for farming industries.
Biotherapeutics
Targeted therapies for enhanced healthcare solutions.
Aquatic Medical Devices
Medical advancements for aquatic life healthcare.
Cosmetics
Beauty and skincare innovations for enhanced personal care.
Polymers
Advanced polymer solutions for diverse industries.
Agro Chemicals
Sustainable agro-chemical solutions for modern farming.
Special Chemicals
Innovative chemical solutions for industrial applications.
Drug Pellets
Revolutionary drug pellet formulations for improved delivery.
Nano Technology
Advanced nano-technology solutions for various sectors.

Testimonials

20K+ Satisfied Clients World Wide