Ready for a VVKT inspection
Deviation and CAPA register, driver GDP training records, vehicle qualification and calibration certificates, all exportable. Nothing is reconstructed after the fact, because the record is created as the shipment moves.
EU GDP Guidelines 2013/C 343/01 require that the storage and transport conditions of a medicinal product are documented and reviewable, and Annex 15 requires that the equipment doing it is qualified and revalidated. We generate that documentation as the shipment moves, from the same records our own quality manager works from.
A licence number beats a badge icon. These are the entity details a qualified-person audit asks for first.
Held by UAB Transpharmacia, company code 300662544, in the register of the Lithuanian State Medicines Control Agency. Ask us and we send the authorisation record with the entity details above.
quality@transpharmacia.ltWhat happens between the sensor and the closed record, in the order it happens.
The excursion engine sees the breach and waits out the grace period held in the pricing parameters.
A deviation record opens by itself and the consignment is marked as under review.
The dispatcher and the Responsible Person are notified in-app and by email in the same second.
The client is told on the tracking page and in the delivery pack, without having to ask.
The quality manager records root cause and CAPA, and only then can the record be closed.
The register exports for a VVKT inspection with every record and its evidence attached.
739 of 740 deviation records are closed with a root cause and a CAPA on file.
Deviation and CAPA register, driver GDP training records, vehicle qualification and calibration certificates, all exportable. Nothing is reconstructed after the fact, because the record is created as the shipment moves.
A designated Responsible Person for GDP reviews every deviation. Drivers are trained and re-trained on GDP transport, and their records expire visibly 30 days before the date, not after it.