Institute of Validation Technology’s 11th Annual Meeting/Validation Week

Ensuring the Integrity of Electronic Records and Signatures: An Internal Controls Approach
I. The Concept of Internal Controls

• Policies and procedures related to the use of computerized systems
• Benefits of building the policies and procedures into the infrastructure

II. Detailed Description of Internal Controls

• Providing a detailed definition of each control
• Relating the disparate controls into a logical construct of a controlled infrastructure

III. Traceability to Regulatory Requirements

• Specific internal controls to the requirements enumerated in applicable regulations

At the conclusion of the workshop, the participants will be able to:

• Understand the control environment that is conducive to compliant and efficient automated operations
• Identify the pertinent internal controls
• Relate the internal controls to requirements of applicable regulations