The Complete Regulatory Suite

Complete Suite Contents

  • Everything in Professional

  • EU MDR Technical Documentation System (GSPR mapping, Annex II/III structure, risk integration)

  • FDA QSR / 21 CFR 820 Document Set (SOPs adapted for US FDA, IFU/label formats, advisory notices)

  • Sterilization & Sterile Barrier Validation Pack (sterilization VMP, load sheets, packaging validation, IQ/OQ/PQ)

  • Records & Registers Master System (complete master register list + record templates)

  • Supplier Quality Agreement Pack (full QAA template, responsibilities matrix)

  • Full SOP Library (Document Control, CAPA, Complaints, Supplier, D&D, PMS, RM, Validation, etc.)

  • Full Training Slide Deck Library (all systems, regulatory fundamentals, modules)