Documentation - After several failed validation activities on a new fully automated packaging line, NPC was involved to finalise the project. The task was to support the local project management and validation team. The Equipment was installed in the US which required remote management and several on-site visits for the validation execution.
NPC was asked to play a key role of the impementation of serialisation equipment for a Danish parallel trader to reach the EU Falcified Medicine Directive deadline. The project scope reached from overall strategy and vendor selection to final solution implementation.
NPC was asked to re-organise the documentation package for a previous packaging line. The restructured validation documentation was asked to be presented on another site to frontload the local project and reduce overall project time.
NPC was asked to update documentation related to various IT environments of the serialisation site server. The task included providing key elements to the change control as well as support the cutover activities.
A Danish client requested our help with project scoping, vendor selection and final rollout to upgrade an existing packaging line for upcoming regulatory changes. The project had a tight budget with very limited resources allocated. NPC was involved from the very early stages of solution scoping to the final installation. Due to long delivery times from the suppliers, the project included several months of pause. NPC was asked to also support the validation process of another site in the meantime.