FormaliS provides you support when an inspection from authorities is anticipated, announced and/or conducted.


  • Preparation and training of teams to get ready for¬†inspection
  • Facilitation of inspections by being present while the¬†inspections are carried out


  • Development sites
  • Validation sites
  • User sites
  • Service providers
  • Sponsors


  • 21 CFR part 11
  • Computerized Systems in Clinical Trials
  • GAMP standard and applicable regulations