Fully Compliant!

In March of 1997, the United States Federal Drug Administration (FDA) issued final Part 11 regulations that provide criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records by the FDA as equivalent to paper records and handwritten signatures executed on paper under certain conditions.

21 CFR Part 11 became effective in August 1997 and since then has been constantly revised and narrowed to minimize the efforts for the industry whilst protecting the public health efficiently.
After several optimizations steps, the FDA today is intending to enforce provisions related to the following controls and requirements:1

• Limiting system access to authorized individuals
• Use of operational system checks
• Use of authority checks
• Use of device checks
• Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
• Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
• Appropriate controls over systems documentation
• Controls for open systems corresponding to controls for closed systems bulleted above
• Requirements related to electronic signatures

1 Part 11, Electronic Records; Electronic Signatures – Scope and Application