Using Electronic and Digital Signatures in Regulated Environments

Why Should You Attend:

FDA Part 11 and other regulations such EU GMP Annex 11 allow to sign electronic records with electronic and digital signatures. Benefits for regulated user firms are increased overall efficiency and reduced costs for handling and storing paper records. While nearly all Part 11 related papers and seminars deal with requirements of electronic records there is hardly any information about electronic and digital signatures. Therefore most companies are unsure about electronic signatures such that they print out copies of electronic records and sign the paper.

In this seminar attendees will become familiar with FDA requirements for electronic and digital signatures. Free Hand-outs:

For easy implementation, attendees will receive

  • 2 SOPs
    • Using Electronic Signatures in FDA Regulated Environments.
    • Access Control to Computer Systems and Data.
  • Checklist: Using Electronic Signatures in Regulated Environments.
  • Example: Requirement Specifications for Electronic Signatures.
  • Tutorial: Getting and using Digital Signatures for E-mails.

Areas covered in this webinar:

  • Definitions of electronic vs. digital signatures.
  • Benefits of electronic signatures.
  • Examples of using e-signatures day-by-day.
  • Part 11 requirements for electronic signatures?
  • European and international requirements.
  • Applications and requirements of digital signatures.
  • Inspection and enforcement practices.