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COMPLIANCE

Legislation
  • 21 CFR parts 210, 211, 11 & 820
  • EU Guide to GMP
  • Clinical trial directive
  • Medical device directives
Standards
  • ISO 9000 series
  • ISO 14001
  • ISO 26000
Guidelines
  • PS9000 series
  • ICH
  • Health Technical Memoranda
  • GAMP
QMS Strategies website sharon@qms-services.co.uk