QCLYNX can help your organization tackle the validation process with confidence and eliminate unnecessary expenditures. Our validation services can range from a complete system review and implementation to basic compliance assistance and consulting. The bottom line, we customize your validation project to meet your existing needs and budget limitations. Our CSV Consultants specialized in GAMP5, FDA 21 CFR Part 11, and PIC/S annex 11.
Ensuring your internal systems, or those of your suppliers or clients meet the necessary requirements, is essential before undertaking any regulatory process. Additionally, adhering to good practice (GxP) guidelines is essential to demonstrate to regulators that all aspects align with their standards.
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organization to ensure product quality and patient safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards regulatory agencies.
We offer advice, guidance, and solutions in the following areas
Providing Consultancy, Gap Analysis, and Operational Support on GxP Topics
Preparing and supporting regulatory inspections
Software Vendor Audits or Prequalification Audits
Hosted Services Audits (SaaS)
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