THE ORANGE COUNTY CHAPTER OF THE PROJECT MANAGEMENT INSTITUTE presents...


APPLYING THE GOVERNANCE MODEL

For each task on the project plan, identify where it falls in the governance model. Hover your mouse over the box to see a suggestion. Click here to see all the suggestions

Step 1:
Software Risk Assessment addresses risks to human safety

Consciousness

Software Validation Plan uses the best practices for testing software

Wisdom

Cybersecurity Policies and Procedures for the GLP Laboratory addresses risks to lab safety

Wisdom


Step 2:
User and Functional Requirements Specification identifies how lab equipment functions

Understanding

Begin the Test Plan to test that the lab equipment works

Understanding

Begin the Traceability Matrix to show how tests validated requirements

Information


Step 3:
System Design and Configuration Specification describing how the system works

Information

Update the Test Plan

Step 4:
Finalize the Test Plan
Finalize the Traceability Matrix

Step 5:
Installation Qualification Protocol to test the environment and installation provides Data

Data

Operational Qualification protocol to test software functions provides Data

Data

Performance Qualification Protocol for performance testing provides Data

Data


Step 6:
FDA CFR Part 11 Assessment to demonstrate compliance with regulations provides Knowledge

Knowledge

Validation Summary Report proving that the system functions properly

Information

QA review to agree that the lab equipment functions properly

Understanding


Step 7:
Standard Operating Procedures for Analyst Software to ensure the lab equipment continues to function properly

Knowledge

Standard Operating Procedures for GLP Lab Cybersecurity to ensure the safety of the lab

Knowledge

Outline Next