QUALITY AND COMPLIANCE

 

The implementation of a quality system is necessary for all companies in the health segment so they are able to meet the requirements of regulatory agencies for the manufacture, storage, import and distribution of products regulated by ANVISA, in addition to ensuring the safety, quality and maintenance of related processes. The implementation of systems constitutes of:

  • Preparation or revision of standard operating procedures;
  • Quality manual;
  • Attention to regulatory requirements related to inspections of local or federal surveillance;
  • Training of team members in the procedures applicable to each area;
  • Technical manager qualification to act actively in the system of quality of the company;
  • Qualification of suppliers and service providers;
  • Internal audit;
  • Validation of transport of products for health, medicines and cosmetics;
  • Validation of computerized systems;
  • Thermal qualification of controlled temperature areas;
  • Technical support in the definition of layout for disposition of the products inside the warehouse;
  • Technical visit to evaluate the feasibility of the building in which the company intends to establish itself;
  • Attention of Techno-surveillance (elaboration of report for registration in NOTIVISA);
  • Risk Analysis in accordance with ISO 14971, current version.

OTHERS SERVICES