Compliance


Clinical6 is compliant with applicable sections of:

  • Electronic Records and Electronic signatures (21 CFR § 11 and EU GMP Annex 11)
  • HIPAA Privacy Rule (45 CFR § 160, 162, 164)
  • Quality Management System (21 CFR § 82)
  • FDA Guidance – Computerized Systems Used in Clinical Trials (21 CFR §312.62(b) and §812.140(b))
  • FDA Guidance – General Principles of Software Validation
  • ICH GCP 5.5.3
  • sections a-g and Local
  • State Regulations