OCELLOS allows treatment centres to print compliant, customized shipping and product labels for starting cell samples and similarly for manufacturers to print shipping and product labels for finished drug products. This gives the therapy developer or pharmaceutical sponsor the ability to include these label records as part of the audit trail, to support both Chain of Identity (CoI) and Chain of Custody (CoC).
OCELLOS will record each instance that a label has been generated and asks the user to verify that the label has been printed correctly. All of this helps to ensure there is a time-stamped and user identified audit trail available.
With clinical trials broadening and increasing commercialisation increasingly spanning wider geographies and multiple languages, ensuring that labels are printed in the best format possible to ensure quick delivery, customs clearance and correct handling is critical.
There are a number of ways of achieving this but given that much of the dynamic/personalized content of the label is numerical, reference numbers or address information, it is not necessary to create a full, local language version of the OCELLOS platform in order to achieve local language labelling, particularly if full translation is not required for other elements of the process.
OCELLOS can store the constant elements of the label (such as storage warnings or handling information) within multiple label templates in the various languages that are required. The system will then select the correct template based on the criteria you choose, e.g. the country of the treatment site.
This means that the label preview will display in the local language in a pre-approved template format with the correct patient id, volume and delivery information in place. So the user can continue to check the information that they have input ahead of printing.
The local sites/users simply continue to input the information that eventually displays on the shipping labels as normal into OCELLOS but when generated, the label will be output in the chosen language template, making it easier for shipping and handling, customs and regulatory to ensure the product is handled quickly and correctly.
This means that whichever user in the therapy journey that originally enters the information for the label, e.g. Collection nurse, Manufacturing Technician etc. the output will always be in the correct format based on the language rules that have been set without any need for re-training or language selection on local sites.
Looking for an orchestration solution to help your users manage an international supply chain? Why not contact the TrakCel team who will be happy to share tips and advice on practices and automation that can help take away the complexity.
Article by Helen Hopkins - 23 Aug 2022