Skip to main content

menu

School of Medicine & Dentistry / Office of Research IT / Research IT Services / Adobe Acrobat Sign CFR Part 11 Compliance / FDA Controls for CFR Part 11

 

FDA Controls for CFR Part 11

The University must comply to FDA mandated standards. Office of Research IT will maintain a closed system to maintain the necessary rigor meet the compliance standards.

The FDA requires that we maintain all documents electronically. Office of Research IT will ensure using a closed system to maintain records. We must comply with 21 CFR Part 11 using the closed system and employ procedures and controls designed to maintain electronic records’ authenticity, integrity, and confidentiality.

  • System validation to ensure data security and integrity of record keeping.
  • Audit trail to trace the development of a process.
  • Restricted access for better security control.
  • All system users must have essential training to perform everyday tasks.
  • Quality procedures that instill operational control over people and process within the development cycle.
  • Electronic signature across the organization for a quick and easy approval process.