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).