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