Integration and increased automation are transforming the way life sciences companies manage much of their operational and regulatory information. So it seems odd that labelling and packaging content – so critical to market acceptance and patient safety – remains subject to very separate, manual processes, leaving organisations open to unacceptably high risk of error as well as considerable inefficiency. There must be a better way, says Amplexor’s Romuald Braun in the Journal for Clinical Studies .
As long as product labelling is treated as a distinct, manually- driven process, life sciences organisations will continue to leave themselves open to the risk, not to mention a level of inefficiency they can ill afford. Mislabelling is one of the leading causes of costly product recall and a particularly frustrating one given that it is so easily preventable.
So it is probably no bad thing that increasingly strict regulatory requirements and the imminence of IDMP are causing regulatory and quality teams to review their processes and systems for managing content. It was in this context that labelling management came up as a prominent topic at Amplexor’s recent annual customer conference.
The Bigger Picture
As life sciences organisations start to think more laterally about regulatory information and greater efficiency in how they respond to new demands, they are beginning to realise that the only real way to manage this in a sustainable way is by creating and drawing from a definitive master data repository that is capable of supporting multiple applications. Instead of starting from scratch each time there is new content (such as new labelling) to create, regulatory teams and those responsible can simply call up approved content from a central resource.
This approach becomes a natural one as organisations move towards a more holistic, next-generation regulatory/product information management strategy. This is the vision advocated by Steve Gens, founder of Gens & Associates, one of the leading authorities on regulatory information management (RIM). He maintains that RIM should be as wide-ranging in scope as possible, encompassing dossier management, submission planning and tracking as well as manufacturing, change control, safety reporting, master data management, and labelling and document management.
As long as such activities take place separately, each served by standalone systems and processes, companies risk repeatedly reinventing the wheel and introducing inconsistencies with each new content preparation task. If a company has procured systems for each distinct process from a series of different vendors, integration can be an issue and data’s dominion may be unclear: which is the authoritative, correct version of content and how is this determined and controlled?
Do it Once and Do it Well
Next-generation RIM needs to facilitate a seamless, reliable end-to- end process – from data/content collection to submission tracking and reporting. To further maximise the benefits, companies should be extending this same systematic process of content management to all important product data across a drug’s lifecycle. If this, rather than a targeted application of the data, becomes the core resource, it becomes possible to derive maximum efficiencies each time that content is repurposed for a particular use case.
So ideally, any master data management initiative should start with a product master data object model, of which regulatory intelligence is a part. The regulatory factors may not fit generic system data fields, being the proprietary IP of each company. But if the information is structured, it can still be reflected in the main product information system, contributing to that holistic, 360-degree resource which caters for all information needs.
Combining product master data with regulatory intelligence makes it possible to automate more processes – including labelling management. Suddenly more becomes viable, and the need for heavy manual work is reduced each time there is a new content- related requirement. In the next-generation scenario, whether the result is new labelling or an IDMP-related submission, the output is ultimately just an expression of the company’s product data, in a particular format.
Taking a master data/complete product profile approach means all of the correct content for accurate, compliant labelling can be called up quickly and easily for the given use. In addition to ingredients and manufacture information, it should be possible to call up detail for all authorised medicinal products alongside all the respective countries’ procedures, health authority organisation information and marketing authorisation programmes and processes. Labelling processes, change requests, sequences and templates should all be possible to manage in a clear and structured way.