At FicusRealtime, we offer direct access to highly experienced Subject Matter Experts (SMEs) across key regulated domains including GxP compliance, Computer System Validation (CSV), Quality Assurance, and Data Integrity. Our SMEs bring deep, hands-on knowledge to help organizations achieve, maintain, and scale regulatory compliance in alignment with global standards such as FDA, WHO, EMA, and CDSCO.
At FicusRealtime, our Subject Matter Experts (SMEs) provide targeted expertise to help pharmaceutical, biotech, and healthcare companies navigate complex compliance, validation, and regulatory challenges. With deep experience in GxP environments, our SMEs offer strategic support that enhances quality systems, ensures regulatory alignment, and drives operational excellence.
Areas of Subject Matter Expertise
Computer System Validation (CSV):
GAMP 5-compliant validation planning
21 CFR Part 11 and Annex 11 compliance
Validation document review and audit readiness
Lifecycle management for IT systems and software
GxP Compliance & Quality Systems:
GMP, GLP, GDP, and GCP framework implementation
Internal audits, gap assessments, and remediation support
SOP design, deviation handling, and CAPA systems
QMS optimization and harmonization strategies
Data Integrity & Audit Preparedness:
ALCOA+ principles and gap assessments
Audit trail review and documentation controls
Data governance policies and training
Regulatory inspection support and defense
Equipment & Facility Qualification:
DQ/IQ/OQ/PQ lifecycle protocols
Utility, HVAC, and cleanroom validations
Risk-based approach to
Documentation review and compliance assurance
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
