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Team members
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Countries
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Driving Growth
ABOUT QCLYNX
Empowering Life Sciences Through Seamless Validation and Compliance
Established in 2019, QCLYNX Consulting Pvt. Ltd Expert in life science consulting services. partners with pharmaceutical, biotechnology, medical device, healthcare and other regulated organisations to transition from paper-heavy, documentation-driven validation to efficient, risk-based CSA/CSV approaches that satisfy FDA expectations, GAMP® 5 Second Edition, 21 CFR Part 11, EU Annexe 11 and applicable quality standards. CSA promotes critical thinking and risk-based validation, in line with FDA's Case for Quality initiative that is helping companies validate faster, smarter and with stronger assurance where it really counts. CSA replaces “document everything” with “think critically, test smart”
Our Core Offerings
Trusted Services for Regulated Industries
Audit-ready compliance and risk-based validation services tailored for highly regulated sectors. We help pharma, biotech, and medical device organizations streamline operations while meeting strict global standards.
Computerized System Validation
Ensures software & IT systems in life sciences meet FDA/GxP standards for quality, safety & data integrity.
GxP Audits & Compliance services
Independent audits ensuring full GMP, GLP & GCP compliance, data integrity, and inspection readiness.
Quality Management Solutions
End-to-end eQMS, CAPA, and DMS support to streamline processes and maintain inspection readiness.
Data Migration
Secure, compliant data transfer ensuring total data integrity, zero loss, and full auditability with seamless end-to-end operational efficiency.
Pharmacovigilance
Comprehensive drug safety services ensuring continuous benefit-risk monitoring, global compliance, and audit-readiness.
Regulatory Affairs
Strategic lifecycle support, dossier preparation, & global health authority filing management ensuring regulatory audit readiness.
AI Tool Validation for Regulated Industries
Assess and validate AI tools used in GxP environments with a risk-based approach covering intended use, data integrity, performance, documentation, governance, and ongoing compliance.
We are here to answer your questions 24/7
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Industry Specific
We deliver industry-specific solutions tailored to your compliance needs through our life science consulting services.
Pharmaceuticals
Biotechnology
Medical Devices
CDMOs / CMOs
Clinical Research / Clinical Trials
Laboratories / Testing Labs
Vaccines & Biologics
Healthcare / Hospital Systems
Radiopharmaceuticals
Cosmetics & Personal Care
Food & Nutraceuticals
Genomics / Molecular Diagnostics
Animal Health / Veterinary Pharma
Contract Research Organizations (CROs)
Our Working Cycle
Discovery & Strategy
Aligning project scope, regulatory standards (FDA, GAMP® 5), and risk-based validation frameworks to build a tailored compliance roadmap.
Risk Assessment & Design
Evaluating system impact, data integrity risks, and functional requirements to establish lean, audit-ready testing protocols.
Execution & Validation
Executing IQ/OQ/PQ protocols, data migration checks, and eQMS integrations while resolving compliance gaps in real time.
Hypercare & Audit Readiness
Providing post-launch support, full documentation handovers, and continuous compliance to keep your systems inspection-ready always.
From Leadership to the Front Lines
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.
Prasad Pasupuleti
CEO/Founder
Testimonials
Turning Challenges into Success Stories
Blog Updates
Latest News Posts
- June 12, 2026
- 21 CFR Part 11
10 Common 21 CFR Part 11 Compliance…
Navigating FDA Title 21 CFR Part 11 compliance remains a high-stakes challenge for pharma, biotech, and medical device companies.…
QCLYNX applies a risk-based change assessment approach to vendor releases. We evaluate release notes, system impact, GxP functionality, data integrity considerations, and existing controls to determine the appropriate level of regression testing and documentation.
Our approach is aligned with applicable regulatory and industry expectations, including FDA 21 CFR Part 11, EU Annex 11, GAMP® 5, data integrity principles, and relevant quality-system standards. We tailor the approach based on the system's intended use, GxP impact, and risk.
A GxP Mock Inspection simulates key aspects of a regulatory inspection. We assess documentation, procedures, system controls, audit trails, data integrity, change management, and staff inspection readiness, helping organizations identify and remediate gaps before an actual inspection.
We offer flexible engagement models including fixed-scope projects, time-and-materials consulting, and dedicated compliance resources. Engagements can be tailored to project complexity, timelines, and internal resource requirements.
Yes. We help organizations determine the appropriate assurance approach based on system risk, intended use, complexity, GxP impact, and applicable regulatory expectations. Our objective is to achieve effective assura