03 Jun Managing to improve the pharmaceutical paper trail
The pharmaceutical industry is a hugely important sector of the Irish economy, accounting for 30% of our total exports. Nine out of ten of the largest pharmaceutical companies in the world have a presence in Ireland, with seven out of ten pharmaceutical blockbusters produced here.
While the industry plays such a crucial role in improving the lives of people across the world, it still faces a number of challenges – not least the storage and governance of mission-critical medical practices and information. It’s not surprising that this sector is one of the most regulated industries in the world with documentation being particularly strictly regulated.
Think about the lifecycle of a drug. It involves research and development, formulation, clinical trials, approval and finally distribution. The number of critical documents created during this time is enormous. This is all the more staggering when you realise that only 10% of over-the-counter and prescribed medicines developed make it to market. We never see 90% of drugs created or think about the amount of documents created during their development. In recent years, the number of documents required to meet regulations for pharmaceutical companies has grown hugely. It is not unusual to see a single company with several thousands of procedural documents.
Pharmaceutical companies need to be fully aware of their obligations and highly proactive when it comes to managing critical documents and information flows, particularly in the complex and globalised environments they operate in.
The negative implications can be huge for companies’ reputations and bottom lines if there is a problem regarding document security, access or control. In this sector, documents need to be accessible for many years after they are created for the reference of key stakeholders like regulators, medical practitioners and patients.
Documentation needs to be easily retrievable for many reasons. One of the most important factors is to make everything traceable in case a certain batch of medical products or drugs need to be investigated or recalled. Another reason traceability is essential is as proof that nothing is counterfeit. The European Medicines Agency has a guidance document which aims to implement regulations and better control in this area which will undoubtedly be governed under much more scrutiny in the future.
Finally, the information that pharmaceutical companies own needs to be fully protected and remain secure at all times. Much of it is highly sensitive and confidential. By moving all documents into a digital workflow, it not only improves data protection, security and compliance, it also improves accessibility and processes.
The good news for the pharma sector is that help is at hand. Managed Document Services (MDS) provides a completely integrated and secure approach to information management. It offers a seamless process that adapts easily to the complex nature of document creation, processing and storage, in the pharmaceutical and healthcare industries. Crucially, it also facilitates secure retrieval of documents for review from any location.
With most pharmaceutical companies operating across disparate sites in multiple countries, a scalable and integrated solution from a global partner will also ensure jurisdictional compliance across all regions. It can remove many of the governance complexities which most multinational organisations currently face.
Given the importance of document compliance and governance in this sector, it makes sense to invest in a proven managed document service. Not only will it enable adherence to increasingly complex and stringent industry standards but it will also improve collaboration, productivity and ultimately profitability for those pharmaceutical companies which fully embrace it.
California Biomedical Research Association – Fact Sheet: New Drug Development Process