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
|