Industrial Automation | MCK Automation | São Paulo | Brazil
Sistema de Rastreabilidade
The projects developed by MCK follow the North American Code of Federal Regulations (CFR 21 Part 11) which establishes the regulations of the United States Food and Drug Administration (FDA) on electronic records and electronic signatures (ERES).
Órgão regulamentador norte-americano FDA estabelece os requisitos que os sistemas computadorizados devem atender em relação a registros eletrônicos e assinaturas eletrônicas, nas indústrias farmacêuticas e reguladas, para garantir a integridade das informações de rastreabilidade durante todo o ciclo de vida de um medicamento, abrangendo as fases de pesquisa, desenvolvimento, registro, produção, distribuição e eventuais devoluções.
Applicable only to companies that supply medicines to the North American market, it is therefore of fundamental importance for companies operating in the healthcare sector and wishing to export their products to the United States to comply with the standard.
With a focus on the domestic market, this adaptation becomes interesting since Anvisa (National Health Surveillance Agency) also has an equivalent standard, RDC 301/2019
