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


EXAMPLE TOOLKIT AND PROJECT PLAN

Good news! Here's a toolkit for your 21 CFR Part 11 compliance project. It includes these documents:
  • Software Risk Assessment
  • Software Validation Plan
  • Cybersecurity Policy and Procedure Recommendations for the GLP Laboratory
  • User and Functional Requirements Specification
  • System Design and Configuration Specification
  • Test Plan
  • Traceability Matrix to show how tests validated requirements
  • Installation Qualification Protocol to test the environment and installation
  • Operational Qualification protocol to test software functions
  • Performance Qualification Protocol for performance testing
  • Validation Summary Report
  • FDA CFR Part 11 Assessment to demonstrate compliance with regulations
  • Standard Operating Procedures for Analyst Software
  • Standard Operating Procedures for GLP Lab Cybersecurity

Which of these tasks can be assigned to AI?

One can argue that the simplest type of AI is automation. AI can also reason about problem and identify a solution. Here's a simple project plan. Which tasks or sub-tasks can be automated? Where can AI be used to find solutions?

Step 1:
  • Conduct a Software Risk Assessment
  • Create a Software Validation Plan
  • Adopt Cybersecurity Policies and Procedures for the GLP Laboratory


  • Step 2:
  • Review the User and Functional Requirements Specification
  • Begin writing the Test Plan
  • Begin encoding the Traceability Matrix to show how tests validate requirements


  • Step 3:
  • Review the System Design and Configuration Specification
  • Update the Test Plan


  • Step 4:
  • Finalize the Test Plan
  • Finalize the Traceability Matrix


  • Step 5:
  • Conduct the Installation Qualification Protocol to test the environment and installation
  • Conduct the Operational Qualification protocol to test software functions
  • Conduct the Performance Qualification Protocol for performance testing


  • Step 6:
  • Complete the FDA CFR Part 11 Assessment to demonstrate compliance with regulations
  • Write the Validation Summary Report
  • Participate in a QA review

    Step 7:
  • Write the Standard Operating Procedures for Analyst Software
  • Write the Standard Operating Procedures for GLP Lab Cybersecurity

  • Outline Next