An assessment and revision of the existing project to comply with national and European GDP standards was prepared for the client. After completing the renovation work, validation activities were carried out:

  • User Requirements Specification (URS): Development of the user requirements specification.

  • Technical and Functional Specifications (DS & FS): Preparation of the technical and functional specifications.

  • Risk Analysis/Checklists (RA): Risk analysis and checklists.

  • Validation Master Plan (VMP): Main validation plan.

  • Qualification/Assessment of Warehouse Layout and Engineering Systems (DQ): Qualification and assessment of the warehouse layout and engineering systems.

  • Installation Qualification/Verification (IQ): Qualification and verification of the installation of the warehouse and engineering systems.

  • Operational Qualification (OQ) Mapping: Measurement of the functionality of the warehouse and engineering systems (empty warehouse, without products).

  • Performance Qualification (PQ) Mapping: Testing of the warehouse and engineering systems in operation, considering products and seasonal variations (winter/summer).

  • Final Validation Reports: Summary validation reports.

  • Operational Qualification (OQ) Mapping for Transportation Vehicles: Mapping of transportation vehicles' functionality (in an empty state, without products).

  • Performance Qualification (PQ) Mapping for Transportation Vehicles: Mapping of transportation vehicles' functionality, considering products and seasonal variations (winter/summer).