At FicusRealtime, we provide end-to-end qualification and validation services tailored for the pharmaceutical, biotechnology, and healthcare industries. Our solutions ensure that all GxP-regulated systems, equipment, and facilities perform reliably and meet international regulatory requirements including FDA, EU GMP, WHO, and PIC/S guidelines.
Our solutions ensure that all GxP-regulated systems, equipment, and facilities perform reliably and meet international regulatory requirements including FDA, EU GMP, WHO, and PIC/S guidelines.
Our Qualification & Validation Services
Facility & Utility Qualification:
Cleanroom & HVAC validation
Compressed air, WFI, RO, and purified water systems
Temperature, humidity & differential pressure mapping
Environmental monitoring support
Equipment Qualification (IQ, OQ, PQ):
Installation, operational, and performance qualification
Manufacturing & packaging equipment validation
Laboratory instrument qualification (HPLC, GC, balances, etc.)
Calibration documentation & traceability
Computer System Validation (CSV):
Validation of GxP-critical software and systems
Part 11 & Annex 11 compliance
GAMP 5 risk-based validation lifecycle
Validation Master Plans (VMP), URS, IQ/OQ/PQ, and traceability
Process & Cleaning Validation:
Process validation for manufacturing & compounding
Cleaning validation for critical equipment
Hold-time studies and swab testing protocols
Compliance with ICH and FDA process validation stages
Revalidation & Lifecycle Maintenance:
Periodic review of validated systems
Requalification after changes, upgrades, or failures
Controlled change management with impact assessments
SOP support and audit trail documentation
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
