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Keeping up with changing regulations


Notwithstanding the upcoming implementation of the new EU MDR in May 2020, many organizations in the medical devices, pharmaceutical, chemicals and cosmetics industries are experiencing unprecedented demands from regulatory authorities and consumers alike. Product labeling must be clearer, more informative and published electronically in addition to print. It must also satisfy local legislation and local market requirements tailoring of labeling content to meet these demands therefore is key, as is putting the necessary processes in place to make this efficient and accurate. The problem most organizations have when implementing these processes however, is that they are often done so manually in a way which can hinder efficiency and accuracy. Procedures are often published in an array of formats and dispersed across multiple locations which can become out of date or uncontrolled quite quickly resulting in missing or inaccurate labeling. So, what’s the key to avoiding these roadblocks? It’s all about playing by the rules.  If we can automate many of the manual repetitive processes it’s likely that time savings and quality improvements will be one of the first outcomes we experience.


How can business rules help?


Think of it like a filling in an online application form – the presence of certain fields and whether these have been pre-populated or require you to input data will depend on how you have answered the previous questions. The rules engine will decide whether it needs to insert, delete or update facts in real-time, and prove you with wider benefits to your organisation including:


  • Ensuring your organisation is better positioned to keep up with the pace of change
  • Improving productivity and efficiency
  • Ensuring compliance with policy and regulation
  • Improving customer service
  • Opening new revenue opportunities


What other outcomes can applying business rules help achieve for your organisation?


Minimise the level of human intervention in completing complex tasks


Needing to make repetitive ‘low-level’ decisions manually, where these could otherwise be easily automated, can lead to unnecessary errors. The end result can be costly product recalls, potential fines and brand damage through non-compliance.


Ensure content alignment across all types of labelling 


Where much of the labeling content is held in a range of documents, emails, PDFs and printed documents it can become difficult to construct, deconstruct and reuse labeling content. Transforming existing paper-based artwork management systems and processes to a new digitally-driven environment will help reduce the risk of non-compliance and costly product recalls.


Automate and simplify the capture and collation of labelling content needed to address specific product and market needs 


Digitalizing and versioning each of your labelling assets (logos, warning statements, images, etc.) will ensure each of the variable fields you may need on your labels depending on where the product is going to be sold, and which local market legislation needs to be adhered to, can be auto-populated.


Tailor the system around your own business processes


Adopting a business rules approach to labeling and artwork means that your organization is able to tailor the system around your own business processes, rather than adapting your processes to meet the requirements of the system. It will also mean that by automating manual, repetitive tasks, you will be able to free up your resources, allowing you to attend to higher value activities.