An evaluation of the existing project was prepared for the client, and it was revised to comply with national and European GDP standards. After completing the renovation work, validation activities were conducted:

• Production of User Requirements Specification (URS)

• Production of Technical and Functional Specifications (DS & FS)

• Risk Analysis/Checklists (RA)

• Validation Master Plan (VMP)

• Warehouse Layout Planning

• Installation Qualification (IQ) of Warehouse and Engineering Systems

• Operational Qualification (OQ) Mapping of Warehouse and Engineering Systems (in an empty warehouse, without product), including measurements

• Performance Qualification (PQ) Mapping of Warehouse and Engineering Systems (with product and considering seasonal variations of winter/summer)

• Summary Validation Reports • OQ Mapping of Transport Vehicles (in an empty state, without product)

• PQ Mapping of Transport Vehicles (with product and considering seasonal variations of winter/summer)

A temperature and relative humidity monitoring system from the Czech brand Comet was installed in the warehouse facility.

Additionally, validation/qualification of the product management software was carried out.