According to the company’s validation policy and to the current procedure SMK-RP-014, the following objects are subject to validation:
Validation of premises
- Validation of premises of the warehouse facilities was carried out with assistance of third party organizations having required certificates and took place at all stages, from the design stage to construction stage and commissioning stage, at each warehouse facility;
- During the process of validation, a temperature map of the premises was made.
Validation of refrigeration equipment
All refrigeration equipment used at the group’s warehouses undergoes regular validation procedure.
- The process of validation of refrigeration equipment includes all stages of qualification and is carried out by both the company’s Quality department and with assistance of certified third party organizations
Validation of climate monitoring systems
Validation of testo Saveris climate monitoring system used for monitoring temperature and humidity parameters inside production premises of the warehouses was carried out by the manufacturer of the equipment, which had required certificates
Validation of computerized systems
Validation of LEAD WMS/WMS and Manhattan SCALE computerized warehouse management systems was carried out with assistance of an independent consultant which had had experience in validation of computerized systems and qualification of IT infrastructure in Europe for such companies as Sanofi Aventis Pasteur, Novartis Consumer Health, Galderma, UCB, Pierre Fabre, GlaxoSmithKline , Schering, Roche, Merck, SPMSD, Medtronic, etc.
Validation period :
- Lead WMS – с августа 2013 по март 2014
- Lead WMS – from August 2013 to March 2014
- WMS Manhattan SCALE from April 2014 to August 2015