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RPMS (Regulatory Process Management System)

The RPMS Centre of Exellence (Regulatory Process Management) provides technical and regulatory expertise to clients and consultants.  RPM systems can be split into 5 groups:

  • Electronic document management, with a knowledge produced: ENNOV (ennov5), AVANTEAM (Quality Manager), AXEMBLE (VDOC), QUAL' NET, QUBES, systems under platforms DOCUMENTUM/LOTUS NOTES...
  • QMS (Quality Management Systems ):  Corrective Actions/Preventive Actions, incidents, deviations... such as the Trackwise  application(Sparta Systems)
  • Document assembly (CTD or E-CTD): ISI Publisher, EZ Subs
  • Systems to generate  eCTD (CTD to the electronic format): Liquent, Module File of ENNOV..
  • CRM Systems  (Customer Relationship Management): Siebel, Marriage...

ADN, can accompany you at the beginning by your project with the capture of the users needs and help you to choose the solution most adapted to your needs and the compliance requirements (BPx, GxP, 21 CFR Part 11, 211, 210...).