Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

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