Our services ensure that your computer systems in the life science industry meet industry standards and regulatory requirements. We follow FDA guidelines and best practices outlined in the 'GAMP 5' guide.
QCLYNX provides streamlined GxP compliance solutions, focusing on Vendor Program Management and Inspection Readiness. Our expert team ensures regulatory compliance, aligning with industry standards and guidelines. A strong pharmaceutical quality system is essential for product quality and patient safety, serving as a foundation for regulatory approval.
Our software quality assurance and testing services ensure that your deliverables meet performance, functionality, security, and reliability expectations within the specified timeframe. With over a decade of experience, we employ the latest tools and best practices to guarantee high product quality tailored to global market needs
Effective project delivery strategy hinges on thorough preparation, including understanding business requirements, assessing risks, and considering constraints. Robust controls throughout the project lifecycle ensure alignment with time, cost, and quality objectives.
We ensure IT components meet requirements, comply with regulations like ISMS, 21 CFR Part 11, and Annex 11 for GxP processes, and maintain reliability throughout their lifecycle.
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