Strategic Regulatory Consulting for Accelerated Global Compliance

Computer System Assurance

FicusRealtime delivers risk-based, efficient, and audit-ready Computer System Assurance (CSA) services for regulated industries. CSA moves beyond traditional Computer System Validation (CSV) by emphasizing critical thinking, risk prioritization, and business value—while fully complying with regulatory standards. We help you reduce validation overhead, accelerate innovation, and ensure your systems remain compliant, reliable, and ready for inspection.

At FicusRealtime, we offer comprehensive Excel Sheet Validation services tailored for GxP-regulated industries. Our approach ensures that your spreadsheets used in critical operations are secure, accurate, and compliant with global standards like 21 CFR Part 11, EU Annex 11, and GAMP 5.

FicusRealtime provides end-to-end CSA support, including:
CSA Risk Assessment:
Classify systems based on GxP impact and define assurance levels.
CSA Strategy & Planning:
Develop a scalable CSA plan integrated with your existing QMS.
Critical Thinking Workshops:
Train teams to shift from a documentation mindset to a risk-based approach.
Efficient Testing (Scripted + Unscripted):
Focus testing efforts on high-risk functions; reduce time on low-risk areas.
Digital Evidence & Reporting:
Deliver concise, audit-ready reports, test evidence, and traceability maps.

 

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