Services
Guiding You Towards Success
Training & Mentoring
ISO 13485:2016 Implementation
Temperature Validations and Mappings
ViTres will host a range of training sessions during the year to cover different guidelines and burning issues in the Pharmaceutical Distribution and Wholesale Industry.
The Training sessions will include material from first-hand knowledge gained throughout the several combined years of experience as well as the guidance on the statutory and regulatory requirements as provided by the national (SAHPRA) and international bodies (ISO, ISPE, WHO etc.).
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Bespoke mentorship programs are available upon request.
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The International Organization for Standardization developed and reviewed the ISO 13485:2016 to assist manufacturers of medical devices in designing and implementing a Quality Management System (QMS) that creates and maintains the efficacy of their processes.
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ViTres will interpret the ISO 13485:2016 and any other statutory and regulatory requirements and develop a project plan to assist clients in meeting the requirements. By performing a Gap Analysis, ViTres will analyze and assess the clients’ current systems and operations and determine efficient and cost-effective ways to improve and implement a fully functional QMS.
ViTres provides assistance for Wholesale and Distribution companies in the Pharmaceutical and Medical Devices Industry to obtain and maintain compliance as per the relevant SAHPRA and SAPC guidelines and regulations.
ViTres will ensure that your facility is not only audit-ready but that it also maintains conditions that ensure the quality and integrity of all products being stored and transported by your company .