Qualitice

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 services include: Computer System Validation according to GAMP 5 and corresponding regulations Project Management (SCRUM, SaFE, traditional) Audit Execution and Preparation / Regulatory Compliance within Pharmaceuticals and Medical Device industry Business and IT assessments Strategy and advice on quality, validation and compliance Requirement Engineering Global and local SOP Creation, Review & Approval Data Integrity Strategy & Gap Assessment (ALCOA) Our Approach Qualitice is flexible in the provision of its services, depending on your needs; either on-site, remotely, or a combination of both.