PQ.039 - Project Control

Evolução do Design Control

De processos manuais e documentais para Compliance as Code: Como o nCommand Lite automatizou o PQ.039

Sobre o PQ.039

Procedimento formal de controle de projeto (Design Control) da IONIC Health

O PQ.039 estabelece o procedimento de controle de projeto (design control) para garantir que todos os produtos desenvolvidos pela IONIC Health sejam seguros, eficazes e atendam requisitos regulatórios durante seu ciclo de vida. Baseado na ISO 13485, FDA 21 CFR Part 820 e RDC 665 da ANVISA.

Desafio: O processo tradicional envolvia múltiplos formulários manuais (R039.001 a R039.027), revisões via email, planilhas Excel para rastreabilidade, aprovações que podiam levar semanas, e rastreabilidade manual entre requisitos, código e testes.

Solução: O nCommand Lite implementa "Compliance as Code" através de gates automatizados, rastreabilidade automática (Requisitos → Código → Testes), ferramentas integradas (Azure DevOps, DefectDojo, Terraform) e geração automática de evidências para os formulários R039.XXX.

~70%
Time Savings
Average reduction in process time
100%
Compliance
Automated gates ensure compliance
Real-time
Traceability
Live traceability vs manual updates
70-80%
Automation Level
Automated stages of design control
📊 IMPACTO QUANTIFICADO

Ganhos por Etapa do PQ.039

Redução de tempo e automação implementada em cada fase do Design Control

~70%
Tempo Total Economizado
Média geral do ciclo
100%
Compliance Automatizada
Gates técnicos obrigatórios
Real-time
Rastreabilidade
Requisitos → Código → Testes
9
Etapas Automatizadas
NPJ → OPJ → CPJ → LPJ

Melhorias Detalhadas por Etapa

ETAPA NPJ
Project Request
R039.001
75%
~2-3 weeks for approval → ~1-3 days with automated routing
ETAPA OPJ
Project Charter
R039.002
60%
~1-2 weeks for signatures → ~2-5 days with digital workflow
ETAPA CPJ
Project Plan
R039.003
65%
~3-5 weeks to create and approve → ~1-2 weeks with template-based planning
ETAPA EPJ
Input Data
R039.004
50%
~4-6 weeks for complete input data → ~2-3 weeks with collaborative editing
ETAPA SPJ
Output Data
R039.007
90%
Continuous but fragmented tracking → Real-time, automatically generated
ETAPA RPJ
Project Review
R039.008
70%
~2-3 weeks per review cycle → ~3-7 days with automated workflows
ETAPA TPJ
Project Transfer
R039.005
85%
~1-2 weeks for transfer → ~4-8 hours from approval to staging
ETAPA VPJ
Project Validation
R039.006
60%
~3-5 weeks for complete validation → ~1-2 weeks (E2E automated, usability manual)
ETAPA LPJ
Project Release
R039.009
80%
~3-5 days for release approval → ~4-8 hours from approval to production

Comparação Detalhada por Etapa

Processo tradicional vs automação com Compliance as Code

NPJ
Project Request
R039.001
75% reduction in approval time

Processo Tradicional (PQ.039)

Processo:
Manual project request form submitted via email, reviewed in meetings
Ferramentas:
Word documents, Email, Manual approval tracking, Meeting minutes
Tempo Médio:
~2-3 weeks for approval
Registros:
R039.001 form in Docnix/SharePoint

Processo Automatizado (nCommand Lite)

Processo:
Epic/Feature created in Azure Boards with automated workflow
Ferramentas:
Azure DevOps, Automated notifications, Digital approvals
Tempo Médio:
~1-3 days with automated routing
Registros:
Work Items with full audit trail + R039.001 PDF reference

OPJ
Project Charter
R039.002
60% faster charter approval

Processo Tradicional (PQ.039)

Processo:
Manual charter document with wet signatures, email distribution
Ferramentas:
Word, PDF, Manual signatures, Email
Tempo Médio:
~1-2 weeks for signatures
Registros:
R039.002 signed PDF in Docnix/SharePoint

Processo Automatizado (nCommand Lite)

Processo:
Digital charter in SharePoint with digital signatures
Ferramentas:
SharePoint, Digital signatures, Azure Boards integration
Tempo Médio:
~2-5 days with digital workflow
Registros:
R039.002 signed PDF linked to Azure Boards project

CPJ
Project Plan
R039.003
65% reduction in planning overhead

Processo Tradicional (PQ.039)

Processo:
Manual project plan document with Gantt charts in Excel/Project
Ferramentas:
Word, Excel, MS Project, Manual updates
Tempo Médio:
~3-5 weeks to create and approve
Registros:
R039.003 in Docnix/SharePoint

Processo Automatizado (nCommand Lite)

Processo:
Sprint planning in Azure Boards integrated with project plan
Ferramentas:
Azure Boards, Sprint planning, Automated burndown, Templates
Tempo Médio:
~1-2 weeks with template-based planning
Registros:
R039.003 + Digital sprint plans with real-time tracking

EPJ
Input Data
R039.004
50% faster input data collection

Processo Tradicional (PQ.039)

Processo:
Manual input data document with requirements, manually tracked
Ferramentas:
Word, Excel for tracking, Email reviews, Manual versioning
Tempo Médio:
~4-6 weeks for complete input data
Registros:
R039.004 in Docnix/SharePoint

Processo Automatizado (nCommand Lite)

Processo:
Requirements as Azure DevOps Work Items with SRS versioned
Ferramentas:
Azure Boards, Custom fields for regulatory data, SRS in Git
Tempo Médio:
~2-3 weeks with collaborative editing
Registros:
Work Items + SRS + R039.004 consolidated PDF

SPJ
Output Data
R039.007
90% reduction in manual compilation

Processo Tradicional (PQ.039)

Processo:
Manual compilation of outputs: code, tests, docs separately tracked
Ferramentas:
Manual code review, Excel for tracking, Word for reports
Tempo Médio:
Continuous but fragmented tracking
Registros:
R039.007 manually compiled in Docnix/SharePoint

Processo Automatizado (nCommand Lite)

Processo:
Automatic output generation: code versioned, tests automated, docs versioned
Ferramentas:
Azure Repos, Azure Test Plans, Automated test reports, Version control
Tempo Médio:
Real-time, automatically generated
Registros:
All outputs automatically tracked + R039.007 consolidated PDF

RPJ
Project Review
R039.008
70% faster review cycles

Processo Tradicional (PQ.039)

Processo:
Manual review meetings, email-based code review, separate test reviews
Ferramentas:
Email, Meeting minutes, Manual checklists, Word documents
Tempo Médio:
~2-3 weeks per review cycle
Registros:
R039.008 manually compiled from meeting minutes

Processo Automatizado (nCommand Lite)

Processo:
Pull Request reviews, automated test reviews, integrated risk reviews
Ferramentas:
Azure Repos PR, Azure Test Plans, DefectDojo, Automated dashboards
Tempo Médio:
~3-7 days with automated workflows
Registros:
All reviews automatically tracked + R039.008 consolidated PDF

TPJ
Project Transfer
R039.005
85% faster transfer process

Processo Tradicional (PQ.039)

Processo:
Manual deployment coordination, separate staging setup, manual validation
Ferramentas:
Manual scripts, Email coordination, Manual checklists
Tempo Médio:
~1-2 weeks for transfer
Registros:
R039.005 manually filled after transfer

Processo Automatizado (nCommand Lite)

Processo:
Automated deployment to staging, automated E2E tests, IaC validation
Ferramentas:
Azure Pipelines, Terraform IaC, Playwright E2E, Automated gates
Tempo Médio:
~4-8 hours from approval to staging
Registros:
Automated deployment logs + R039.005 with evidence links

VPJ
Project Validation
R039.006
60% faster validation (automated parts)

Processo Tradicional (PQ.039)

Processo:
Manual validation testing, separate usability tests, manual traceability
Ferramentas:
Manual test execution, Excel test sheets, Manual traceability matrix
Tempo Médio:
~3-5 weeks for complete validation
Registros:
R039.006 manually compiled with test reports

Processo Automatizado (nCommand Lite)

Processo:
Automated E2E tests, automated security validation, automated traceability
Ferramentas:
Playwright E2E, OWASP ZAP DAST, Azure Test Plans, Automated matrix
Tempo Médio:
~1-2 weeks (E2E automated, usability manual)
Registros:
Automated test reports + Usability report + R039.006 consolidated

LPJ
Project Release
R039.009
80% faster release process

Processo Tradicional (PQ.039)

Processo:
Manual release checklist, email approvals, manual tag creation
Ferramentas:
PDF forms, Email, Manual Git tags, Manual SharePoint uploads
Tempo Médio:
~3-5 days for release approval
Registros:
R039.009 manually filled and signed

Processo Automatizado (nCommand Lite)

Processo:
Automated release gates, digital approval workflow, automated tag creation
Ferramentas:
Azure Pipelines gates, Automated Git tags, SharePoint API upload
Tempo Médio:
~4-8 hours from approval to production
Registros:
Automated release logs + R039.009 with digital signature

Design History File (RHPJ) - R039.010

Geração automatizada do DHF com rastreabilidade completa

O Design History File (RHPJ) é o conjunto de registros que comprova que o projeto foi desenvolvido conforme os requisitos planejados. O nCommand Lite automatiza a geração do DHF através de:

  • Matriz de Rastreabilidade Automatizada: Gerada automaticamente a partir dos links entre Work Items (Requisitos), Commits (Código) e Test Plans (Testes)
  • Certificado de Segurança: Gerado automaticamente do DefectDojo mostrando "0 Vulnerabilidades Abertas"
  • Consolidação Automatizada: Scripts que consolidam todos os artefatos digitais em um PDF para SharePoint (R039.010)
  • Rastreabilidade Bidirecional: Links entre formulários R039.XXX no SharePoint e artefatos digitais no Azure DevOps

📋 Resultado: DHF gerado automaticamente com 100% de rastreabilidade, mantendo compliance total com PQ.039 enquanto elimina trabalho manual.

Benefícios Principais

Eficiência Operacional

  • Redução de ~70% no tempo total do Design Control
  • Rastreabilidade automática: Requisitos → Código → Testes
  • Feedback instantâneo via gates automatizados
  • 70-80% das etapas totalmente automatizadas

Conformidade Garantida

  • Gates técnicos impedem desvios do processo PQ.039
  • Rastreabilidade 100% automatizada e em tempo real
  • Evidências geradas automaticamente para formulários R039.XXX
  • DHF gerado automaticamente com matriz de rastreabilidade

Explore o Processo Completo

Veja como cada fase do Design Control é implementada com gates automatizados e compliance por design

Ver Fluxos do Ciclo de VidaVer Detalhamento das Fases