At FicusRealtime, we provide complete Computer System Validation (CSV) solutions to help regulated companies meet global compliance requirements. Our services ensure that your computerized systems are validated, audit-ready, and aligned with regulatory standards such as 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA+).
Our services ensure that your computerized systems are validated, audit-ready, and aligned with regulatory standards such as 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA+).
Our Core CSV Services
CSV Audit & Gap Assessment:
Assess existing systems for GxP compliance
Identify gaps in validation, documentation, and controls
Provide detailed remediation plans and compliance roadmaps
End-to-End Validation Services:
Validation Master Plan (VMP)
Risk-based approach (GAMP 5)
User Requirement Specification (URS), IQ, OQ, PQ protocols
Summary Reports & Traceability Matrix
Data Integrity & Part 11 Compliance:
Review of audit trails, access control, and electronic records
System security and backup validations
Compliance with ALCOA+ principles for data governance
Periodic Review & Revalidation:
Periodic system reviews to maintain ongoing validation
Revalidation support during upgrades, patches, or changes
Change control documentation and impact assessments
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
