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Welcome To QCLYNX
Audit-Ready Compliance, Delivered by GxP Experts
QCLYNX partners with life sciences organizations to deliver practical, risk-based solutions across GxP compliance, computerized system validation, quality assurance, and technology.
2019
Started Journey
Global GxP Compliance Expertise
Flexible & Cost-Effective Engagements
Experienced Life Sciences Consultants
Our Story, Purpose & Vision
QCLYNX was founded with a vision to transform regulatory confidence and bridge the gap between complex compliance mandates and operational efficiency. Over time we have become a trusted compliance partner, helping life sciences organizations to manage GxP compliance, data integrity, and computerized system validation with risk-based approach.
We enable life sciences and regulated organizations with seamless end-to-end validation and compliance solutions. Our goal is to reduce regulatory risk, ensure data integrity and ensure system quality so that our customers can focus on innovation and patient safety.
To become a global benchmark in Computerized System Validation (CSV), Computer Software Assurance (CSA), AI Systems Validation, and regulatory compliance, empowering businesses to achieve seamless compliance, audit readiness, and uncompromised quality in an increasingly digital and AI-driven world.
200
+Happy Customers
35
+Projects Completed
6
+Years Experiance
What We Stand For
At QCLYNX, our core values drive every validation protocol, compliance audit, and system review we deliver:
01
Regulatory- Ready Validation
Our computerized system validation and data integrity practices are aligned with FDA 21 CFR Part 11, GAMP 5, and applicable international regulatory standards, helping organizations maintain strong compliance and stay audit-ready from the start.
03
Uncompromising Data Integrity
We develop unbreachable data governance models that ensure patient safety, uphold public trust, and protect your enterprise value globally, while meeting ALCOA+ principles.
02
Accelerated Compliance
We dismantle regulatory bottlenecks. By integrating smart compliance frameworks early, we protect your innovations while accelerating your product's journey to the global market.
04
Proactive Risk Mitigation
We help organisations move from last-minute audit fire drills to continuous, resilient compliance building strong GxP environments that withstand international oversight and regulatory scrutiny.
CEO/Founder
Leadership & Expertise
Prasad Pasupuleti has over 19 years' experience in Computerized System Validation (CSV), Quality Assurance and GxP compliance in the Life Sciences industry. He has managed complex validation and compliance projects for regulated computerised systems, quality management systems, data integrity and global regulatory expectations. His experience includes FDA regulations, GAMP® 5, 21 CFR Part 11, EU Annexe 11, risk-based validation, CSA, audit readiness and quality systems. At QCLYNX, he partners with clients and cross-functional teams to design pragmatic, risk-based compliance strategies that align regulatory expectations, business goals and operational efficiency.
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