www.epmmagazine.com
usual? chain can collaborate and report back on requirements and related progress. But even this relies too heavily on manual updates and process repetition. And none of this takes into account the fuller safetyregulatory-manufacturing-supply chain continuum. Complete labelling traceability, for compliance, reporting, and safety/ risk management, depends on content and processes being open to easy scrutiny right from one end of the chain to the other - from a safety signal, to the regulatory submission and approval, through to product receipt by pharmacies or hospitals. True end-to-end label and product tracking and change management ideally needs to encompass artwork updates, and followthrough into and beyond warehouses. While up to now, this broader perspective and ambition remains largely aspirational, achieving complete end-to-end traceability and control is something life sciences organisations are increasingly attuned to in their vision for process improvements.
31
Certainly, the bolder and more innovative firms become in their quest to expand their markets and portfolios, and the more they become subject to intensifying regulatory/ public safety criteria, the more meticulous and efficient they must be in their monitoring and process controls.
Certainly, the bolder and more innovative firms become in their quest to expand their markets and portfolios, and the more they become subject to intensifying regulatory/public safety criteria, the more meticulous and efficient they must be in their monitoring and process controls. AVOIDING NEW DEAD-END PATHS To keep pace with regulators’ growing safety controls, companies must upgrade their approach to labelling management with some urgency now. Many already have three-to-five-year change programmes underway, with the aim of establishing holistic, transparent and collaborative global label management environments. These comprehensive plans are encouraging, paving the way for a definitive source of labelling truth, in the form of central master data - from which everything else flows. They allow for intelligent workflow - as an efficient and reliable means to assess the impact of label changes/calculate interdependencies; to drive through changes with
reduced manual intervention; and to facilitate greater collaboration across departmental, country and supply-chain boundaries. Finally, plans should be cross-functional – that is, they should allow for connection with global ERP/manufacturing systems, and the potential for re-use of approved content assets. They should also leave room for future automation – for instance, structured authoring of labels and patient information built from approved master content assets. Being thorough and thinking laterally now will pay dividends later.