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Global medical device companies are increasingly looking at labelling from a strategic perspective. They have recognized that accurate labeling is critical for maintaining compliance, ensuring brand consistency and improving operational efficiency, with all three helping to support business growth. To work as efficiently as possible, labeling needs to be integrated into an enterprise business process, as well as working efficiently with an existing solution. Below, we outline some of the best streamlined approaches organizations can implement for the long-term benefit of their business:

 

Adapt and adopt

 

Life sciences companies need to adopt processes and solutions that will enable them to respond rapidly to change and achieve actionable insights across the entire labeling life cycle. This will enhance collaboration with all relevant stakeholders and improve regulatory operations. Adopting a strategic, enterprise-wide approach to labelling will see both huge benefits, and drive value to companies. By adopting a joined-up approach to managing labeling, text, artwork, packaging and promotional materials, medical device companies will be able to ensure country-specific legislation is obeyed and labelling changes can be made quickly and accurately. There needs to be clear visibility between functions and regions, otherwise companies will struggle to achieve cost reductions and productivity that could otherwise have a positive impact on faster integration of newly acquired businesses. Improved management and visibility of labeling content also ensures better insight of compliance, which equates to greater alignment across artwork, packaging and promotional materials.

 

Managing deviations

 

Having a system that provides all stakeholders with visibility into any regulatory or market driven changes and deviations is of paramount importance to any organisation. Teams of people within an organisation are tasked daily with finding and updating phrases across all labeling documents. A solution which is capable of tracking deviations and having a traceable link back to a single master source of content both reduces the risk of uncontrolled artwork versions and simplifies updates within an organization.

 

Gaining efficiencies and realising cost benefits

 

Life science companies are obliged to prepare and submit a significant amount of labeling content before starting clinical trials. Multiple stakeholders across different departments and regions must coordinate to implement changes affecting numerous interrelated parts. This is highly resource intensive  and a time challenge for companies. This means that medical device companies need to find ways to gain efficiencies with their processes early on in the product lifecycle. But preparing artwork and labeling from structured content drives both quality and productivity, and allows all stakeholders to leverage standardized business assets, such as reusable imagery and phrases. Advances in technology and tools for labeling activities improves processes which involve the collation and storage of content. As a result, activities which typically take weeks to manage are completed within minutes.

 

Transparency and visibility

 

Ensuring transparency in labeling and preventing inaccurate or misleading content should always be a priority. If companies are to remain compliant and easily demonstrate proof of compliance, they must adopt a solution that easily integrates a number of controlled and managed data sources to transform content into compliant labeling components. 

Dave Tarbuck
Dave Tarbuck