Design control and risk management processes

Step-by-Step Breakdown

Detailed explanation of each automated stage in the workflow.

1. 1

   Trigger

   Detect New Design Project

   Monitors Arena PLM for new medical device projects and automatically extracts project specifications, intended use, and device classification. Initiates the design control workflow based on project parameters.

   Arena PLM
2. 2

   Action

   Generate Design Control Plan

   Creates standardized design control documentation including design inputs, outputs, verification protocols, and validation requirements. Automatically populates templates based on device type and risk classification.

   Arena PLMVeeva Vault QMS
3. 3

   Action

   Conduct Initial Risk Assessment

   Performs automated risk analysis using device specifications and historical data to identify potential hazards. Generates preliminary risk management file with hazard identification and risk estimation matrices.

   Greenlight GuruVeeva Vault QMS
4. 4

   Decision

   Evaluate Risk Acceptability Threshold

   Analyzes calculated risk levels against predefined acceptability criteria and regulatory thresholds. Routes high-risk items for additional controls or design modifications.

   Greenlight Guru
5. 5

   Action

   Implement Risk Control Measures

   Automatically assigns risk mitigation tasks to design teams and updates design specifications with required safety controls. Tracks implementation status and residual risk calculations.

   Arena PLMGreenlight GuruSparta Systems TrackWise
6. 6

   Action

   Update Design History File

   Consolidates all design control documents, risk management records, and verification/validation evidence into the master design history file. Ensures traceability and regulatory compliance documentation.

   Veeva Vault QMSArena PLM
7. 7

   Output

   Generate Compliance Package

   Produces complete regulatory submission package including design controls documentation, risk management file, and compliance matrices. Creates audit-ready documentation with electronic signatures and version control.

   Veeva Vault QMS

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