The client requested NPC to assist in the roll-out of a major software update of the installed serialisation site servers. NPC role was: - Impact assessment of installed packaging line equipment - Detailed individual qualification plans per line - Qualification - SOP updates - Liaison between production sites and IT project
PROJECTS
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NPC was asked to take the technical lead on the complex implementation of Russian serialisation and aggregation requirements. The task included deep market requirements understanding as well as technical knowledge on the limitations of installed equipment.
After a successful pre-study project, NPC was asked to continue work for the client by taking on the role as hands on project manager for the implementation of a new fully automated vial inspection machine as well as a fully automated packaging line. The project was a key project for the client to secure the future growth of the business. Limited factory space, a tight schedule, non-optimised packaging material as well as a small project organisation were only some of the challenges that made this project exceptionally complex NPCs role was: - Detailed solution design - Vendor management - Detailed project planning - Shut-down planning - Cost controlling - Packaging material redesigns
NPC was asked to perform a detailed pre-study for the planned purchase of new equipment in order to support the rising demands of the clients products. NPC deliverables were: - Budget - Solution design - Vendor selection - Contract negotiations - Business case establishment - Detailed project planning - Project organisation establishment
NPC was asked to support the onboarding of various market's dynamic coding and serialisation requirements. The tasks included: - Formalising requirements - Change control input - Impact analysis on product portfolie - Artwork impact analysis - Master data management - Detailed roll-out planning The project required alignment across multiple key departments of the client.
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.
The client requested support in standardising and controlling the process from serialisation related market requirement changes to the final imprint on the packaging line. The task included strong stakeholder management and overall business alignment.
NPC was asked to manage the cut-over planning for a serialisation site server update. Additionally it was requested to support the update of related SOPs including training in new processes.
As part of various standardisation strategies, NPC was asked to define a company standard for the imprint of batch data after the implementation of serialisation. NPC had to investigate the capabilites of different implemented print and vision systems as well as regulatory requirements. The standardisation covered the imprint of cartons, bundle labels, shipper case labels and pallet labels.
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.