Audit & Assessment Services

We offer various audit services: from preparing you for an upcoming audit or carrying out an audit on your behalf. We help you to simplify and to well-organize the workflow and collaboration process to compile audits in order to be compliant with FDA, ISO, TüV Süd/Nord, QM and general audit process regulations.

Our solutions

your benefits

Solution

Internal & external GxP- and FDA readiness audits  
Mock and customer audits
Data Integrity audits
CSV audits & Periodic Reviews
FDA Pre-Approval Inspection preparation
Conduct Quality audit  to ensure MDR compliance
Act as ISO 13485, ISO 9001 auditor / audit preparation
Act as GMP/ GDP auditor/ audit preparation
IT supplier audit

Benefits

We ensure your organization is up to speed with all relevant regulations and guidelines required for your upcoming audit. We can provide you with an audit and action plan, perform gap assessments and support you through the entire audit process.

Find out more about our solutions, sucess stories and relevant topics.

Testimonials

Blog entry

Meet our expert

Nilofar Suha

Pharmacist / Senior Manager Quality & Compliance

By joining Digital Chameleon, Nilofar Suha serves her clients with a wide-range of highly specialized, independent Healthcare consulting services that empowers them to work better, faster and more profitably. She leverages 8 years of professional experience during which she acquired a deep knowledge of the key managerial and operational aspects of medical institutions in particular and the Healthcare industry as a whole. Being a certified pharmacist, and by focusing on advanced Lean Management methodologies, Nilofar Suha’s expertise goes beyond the Medical and Pharmaceutical sectors to serve a full spectrum of industrial and manufacturing clients. During her time at Fresenius Kabi, Nilofar Suha had the opportunity to put into action all her years of multi- disciplinary experience, developing Medical Devices for Nutrition and After Care in hospitals, and rehabilitations with key customers. Furthermore her expertise in the operational aspects of the medical sector allowed her to advise on product strategy, as well a plan and backlog for eHealth products, such as "Nutrition Manager" (NM), "Transition Manager" (TM) and "Marketplace" (MP). Her clients include Fresenius Kabi Digital Lab, Cantonal Hospital Basel and Röntgeninstitut Bellevue Zürich AG, Universitätsspital Zürich, Neuroradiology and Clinic Bogenhausen in Munich.