1. Access Limitations – Assess Current Procedures and IT systems to ensure the following requirements

1. Access Limitations – Assess Current Procedures and IT systems to ensure the following requirements are adhered to:

2. Audit Trail - Assess Current Procedures and IT systems to ensure the following can be verified:

3. Date and Time Controls: Assess IT systems for Adherence to the following requirements:

4. Assess Current Procedures regarding External Security to ensure the following requirements are met

4. Assess Current Procedures regarding External Security to ensure the following requirements are met:

5. Direct Entry

6. Data Retrieval – Ensure Processes for retrieval of Data capture the following requirements:

7. Data Review – Ensure Review processes meet the requirements outlined:

8. System Controls

9. Change Management – Assess Current Operational Change Control and IT and Automation change Control

9. Change Management – Assess Current Operational Change Control and IT and Automation change Control Processes ensure the following:

10. Validation – Assess the Validation of each system to ensure it is validated for its intended use

10. Validation – Assess the Validation of each system to ensure it is validated for its intended use in accordance with the following requirements:

11. Documentation Management

12. Training

System Complies with Requirements?