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