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

Activity:

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

Scope:

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

Standards:

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