15:30 – 16:30
Farmaforum Workshop Room 1
Paperless Validation: A necessity in the optimization of the validation / qualification process. Case Study Presentation: White Room Qualification
Marcel Porta, Consultancy Manager Spain
The Validation life cycle involves a long, tedious, time-consuming and paper-consuming editing – approval and execution flow. Added to this is the subsequent difficulty of managing this documentation, its archiving and subsequent retrieval. The use of database software that adopts a document-centric approach and offers all the advantages of electronic and paperless management optimizes the entire validation lifecycle and saves tons of paper. It facilitates project management, promotes standardization, guarantees traceability, ensures compliance with Data Integrity concepts, provides real-time information on the status of the various documents, enables electronic execution and automatic generation of queries and reports on validation status, and the database itself is the final document archive. Moreover, at a time when the sustainability of the planet is a priority, the use of these solutions should be encouraged. It is not the future of validation, but a reality that is already here. A case study on the Periodic Qualification of Clean Rooms is presented.