Issued by: Director, Quality Assurance · Mediclue Technology Pvt. Ltd., Ahmedabad
POLICY STATEMENT
Mediclue Technology Pvt. Ltd. is committed to designing, manufacturing and commissioning controlled-environment systems of the highest quality — systems that our customers can validate, regulators can audit and end-users can trust. We achieve this through a culture of compliance, continual improvement and accountability.
We are committed to understanding and exceeding the expectations of our customers — pharmaceutical manufacturers, hospitals, research institutions and life-sciences companies — by delivering products that perform reliably in the most regulated environments in the world.
Every product we design, fabricate and commission is developed in strict conformance with applicable regulatory standards including ISO 9001:2015, WHO-GMP, EU GMP Annex 1, ISO 14644-1 and ASME BPE. Compliance is not optional — it is our baseline.
We continuously review and improve our manufacturing processes, quality management systems and engineering practices. Internal audits, non-conformance reviews and customer feedback are systematically used to drive improvement.
Critical manufacturing and commissioning processes are documented, validated and controlled. We maintain complete traceability from raw material procurement through fabrication, testing and final delivery — supporting your IQ/OQ/PQ validation requirements.
Our engineering and quality teams receive regular training on applicable standards, regulatory updates and best practices. We believe quality is the responsibility of every individual in our organisation, not just the quality department.
We maintain a qualified supplier list and conduct periodic audits of critical material vendors. Only approved and tested materials enter our production facility.
Certified & Compliant With
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Email: mediclueco@gmail.com
Mediclue Technology Pvt. Ltd., 150, Vivekanand Industrial Park, Kubadthal Road, Kubadthal, Ahmedabad — 382433, Gujarat, India.