Idec Validation Projects

IDEC Validation has vast experience in all areas of compliance, quality and project management.

Examples of projects we have worked on are:

  • Active Pharmaceutical Ingredient facility - management and execution of all qualification activities for a brand new API facility, including clean rooms, HVAC, services, workflows, production equipment and DCS control system.
  • SCADA - Supervisory Control and Data Acquisition system for a pharmaceutical development facility
  • SAP R/3 version update, including risk based assessment to focus the requalification on GMP critical transactions
  • LIMS - Laboratory Information Management System - including the qualification of the centralised infrastructure and preparation of document templates facilitating the system rollout to different operating sites globally. Providing maintenance support for the installed system in a local operating site.
  • CDAS - Chromatography Data Acquisition System - including the qualification of local infrastructure. Development of document templates for use throughout the European deployment. Providing maintenance support for ongoing oeprations.
  • QA Support - Acting on behalf of our client as their QA represeentative for the rollout of computer systems throughout the European region.
  • MES - Manufacturing Execution System - Implementation of the infrastructure, including Windows and Linux servers, both hardware and virtualised.

Examples of production equipment that we have qualified include:

  • Autoclaves
  • Rotary Tablet Press
  • Fluid Bed Dryers
  • Granulators
  • Film Coaters
  • Blister Packing Machines
  • Low Shear Blenders
  • Y-Cone Blenders
  • Vibratory Sieves

“Risk based compliance for Electronic Records and Electronic Signatures in accordance with 21CFR11, EU GMP Annex 11, GAMP guidelines and industry best practice”