🇧🇷Brazil

Sobrecusto em Qualificação Prolongada IQ/OQ/PQ

2 verified sources

Definition

Processo manual extenso de IQ/OQ/PQ causa overtime, equipamentos parados e Custo Brasil ampliado por complexidade regulatória.

Key Findings

  • Financial Impact: R$5.000 - R$15.000 por equipamento (100-200 horas x R$150/hora); 2-4 semanas de capacidade ociosa
  • Frequency: Por cada novo equipamento ou mudança de processo
  • Root Cause: Protocolos manuais sem templates digitais, testes repetitivos

Why This Matters

The Pitch: Fábricas farmacêuticas no Brasil gastam R$200.000+ por equipamento em qualificações demoradas. Padronização digital reduz para 50% do tempo.

Affected Stakeholders

Engenheiro de Processos, Técnico de Manutenção, Planejador de Produção

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

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