Assuring Fitness for Intended Use. Protecting Data Integrity
Yashfin provides Computerized System Lifecycle (CSL) assurance services using a risk-based verification (RBV) approach, ensuring regulated computerized systems are fit for their intended use and maintain data integrity throughout their lifecycle.
Our services move beyond traditional document-heavy CSV by focusing on patient safety, product quality, and data integrity risks, in line with ISPE GAMP® 5 (2nd Edition), while remaining fully compliant with 21 CFR Part 11, EU Annex 11, and GxP expectations.
Computerized System Lifecycle (CSL) Assurance
We support computerized systems across their full lifecycle:
Applicable systems include QMS, eQMS, PV databases, LMS, DMS, RIM, ERP, and laboratory systems.
Risk-Based Verification (RBV)
Our RBV approach ensures verification effort is commensurate with risk, not system complexity.
This approach provides defensible, inspection-ready assurance of system fitness for intended use.
Data Integrity Assurance (ALCOA+)
Data Integrity is embedded across the CSL, not treated as a one-time activity.
By aligning governance, procedures, and technical controls, we create a strong and reliable foundation for data integrity.
Our Services
Contact Us
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B04-332, Business Center 03, RAKEZ Business Zone-FZ,
Ras Al Khaimah, UAE - +971 55 895 5849
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info@yashfin.net
info@yashfinpharma.com
Our Brochures
Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.