Integra2 validates its information system, confirming compliance with the existing EU GDP regulatory framework relating to GDPs for Medicines for Human Use (Guideline 2013/C 343/01) and annex 11 on EU GDP IT Systems, in collaboration with the consulting company ASSI Sistemas e Intrumentación S.L. (a company specialising in advisory and validation services for the pharmaceutical sector).
The final validation report on Integra2’s IT system gathers together the compliance with the tests carried out, defined in relation to the following scope:
• IQ: Verification of design, configuration and functional documentation.
• OQ: Verification of the operation of the system (pick ups, goods out, goods in, temperature, alarms, shipment traceability), verification of logical security, checking of the audit trail, checking of the copying of data for back up and restoration, checking of the starting up and shutting down of the system and checking that the appropriate and up-to-date procedures are in place.
• PQ: Repeated monitoring of the habitual operation of the system.
The validation demonstrates that the Integra2 transport and distribution system is fit for its intended use. Evidence has been provided that the information system guarantees the reliability and repeatability of transport management via Alertran ®.
The number of processes and operations automatically managed by it is increasing day by day. Their efficiency must be compared, given that it directly affects the physical, traceability, administrative and temperature flows of every shipment. In Integra2’s case, it has been helped by already having a uniform system that has been perfectly implemented in every one of the Network’s logistics platforms, and which works with unique data and replicates standard processes.
The validation has demonstrated that the system is robust, safe, efficient and effective.