Unlocking the value in industry regulations


Pharmaceutical businesses are facing a range of new challenges as they manage information to meet continuously evolving industry regulations

The recently introduced Identification of Medicinal Products (IDMP) standards are designed to support the unique identification and exchange of regulated information. Their ISO-defined data elements and structures, related to substances, dosage forms and units of measurement, should go some way to address fundamental ambiguities concerning how medicines are packaged, marketed, sold, dosed and consumed in different countries.

GS1 standards are also being adopted as a way to share consistent and accurate product information, and even more new legislation is not far off. The EU Falsified Medicines Directive is set to be implemented by 2019, and this will require additional safety features on packaging, including GS1 barcodes to support product authentication.

Meeting the requirements of these regulations will undoubtedly be complex, but businesses should consider ways in which they can take advantage of their implementation and how they could be used to add value to existing business processes and the development of customer relationships.

Although IDMP standards, for instance, are used to facilitate the exchange and tracing of information between regulators and different organisations, they could also be used as an effective way to disseminate information between departments within a business.

The MDM platform

A central resource will be required if businesses are to achieve the levels of compliance and efficiency needed to meet these standards. Clearly a significant undertaking, the creation and management of such a resource could be eased with the implementation of a Master Data Management (MDM) platform to support a unified and trusted view of key pharmaceutical business data, such as medicine ingredients, product marketing information, contact information for those responsible for products, and the vast amounts of associated reference data.

Efficient clinical operations and healthcare provider procurement offices rely on the availability of rich, up-to-date, accurately referenced product information. The need to find methods of simplifying and unifying the collection of this information increases along with the volume and variety of medical supplies and, supported by technologies such as MDM, standards in information collection and distribution can help to meet this need.

Accessible and available to all

MDM is a discipline in which business and IT work together to ensure the uniformity, accuracy, stewardship, semantic consistency and accountability of a company’s master data — the data that describe key business facts — making it accessible and available to all of the systems and people that need it, both within the company and beyond.

Creating a consolidated and centralised repository from which trusted information can be authored to support regulatory compliance and digital transformation initiatives, an MDM platform also has the advantage of allowing a company to consolidate duplicate data from many silos, improve data quality and control the enrichment of information for wider usage. In doing so, a business can better support its own operations, sales and marketing activities while, at the same time, supporting collaboration with its partners and dialogue with its customers.

As well as being used within the pharmaceutical industry to manage medicinal product information, MDM can also be employed as a means of supporting the governance and sharing of other business-critical information, such as that pertaining to clinical trials, financial reference data or the various varieties of associated reference data. It can help to support the mapping of product and order codes, enabling manufacturers and their customers to reduce the number of invoicing errors.

Essentially, by implementing an MDM solution, a company will be able to collect information from its existing systems and ensure that it can be used by everyone across the business: sales and marketing manufacturers, customer service operatives, finance teams responsible for invoicing and compliance teams charged with meeting the requirements of new and existing standards. This information can be enriched to meet a number of business needs, such as analytics, compliance and customer support and, by collecting as much as possible from across the supply chain, a business can enjoy a complete end-to-end view of a product’s lifecycle, improving traceability and recall mechanisms. 

Probably of most importance to a pharmaceutical company is the ability that an MDM solution offers to effectively create and manage a central product dictionary, complete with accurate, consistent information on every one of its products and their components.

An holistic view

With various internal departments holding their own respective information in separate files and very often in different formats, product and customer information will tend to be held in silos by most pharmaceutical companies. Working alongside a company’s existing enterprise resource planning (ERP) system, however, an MDM solution will help to address this issue. The ERP will manage the discipline processes within a line of business while MDM manages information governance at a corporate level.

Agnostic of any business processes, an MDM system is able to collect information from a variety of different sources, in a variety of different formats, from where it can be defined, understood, enriched, synchronised and organised in support of company wide initiatives such as business analytics, compliance and customer services. In addition, an MDM solution is able to provide specific information views, designed for a specific purpose, for those users who require this.

Healthcare providers, for example, will be able to provide their customers with information regarding the ingredients, effects and possible side-effects of any given medicinal product, whenever required. Each of a particular pharmaceutical manufacturer’s products can be connected with each of its component ingredients from every one of its suppliers. Ultimately, such visibility will offer an holistic view of a company’s information, enabling greater traceability of data on ingredients and formulae throughout the entire supply chain.

The success of IDMP and its fellow upcoming standards will be measured by levels of performance in patient healthcare, wherever in the world it’s delivered. An MDM platform can play a key role in ensuring that pharmaceutical businesses are able to meet their requirements, remaining fully compliant within all the territories in which they operate, and sufficiently agile to support new regulations as and when they’re introduced.

Trusted sources of master data, sitting alongside existing systems, will help companies throughout the pharmaceutical industry to take an important step toward implementing new standards such as IDMP while, at the same time, delivering greater efficiencies and business benefits.