Qualitice is a dynamic consulting agency for IT Quality & Compliance within the Healthcare industry founded by Anne Woitzik, MBA. The company caters for industries that need to follow strict regulations like biotech, chemicals, drugs, and medical devices.
Examples of Qualitice's consultant clients are major life science companies as well as small and medium-sized companies.
Qualitice develops and implements strategies for regulatory IT compliance and Quality topics within the Life Science Industry, such as Medical Device ,Pharmaceutical or Chemical companies.
Our Approach: Qualitice is flexible in the provision of its services, depending on your needs; either on-site, remotely, or a combination of both.
Planning and implementation of all Computer System Validation activities, including all life cycle documentation according to business and regulatory requirements (incl. GAMP5)
Management, coordination and execution of Data Integrity Gap Assessments and Data Maps (data flow diagrams) to identify Data Integrity risks (according to ALCOA)
Execution and coordination of initial and detailed (GxP) risk assessments and analysis regarding regulations, policies, standards and scientific literature (FDA,WHO,ICH)
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