Labeling: Unlocking the Locked-In Data

Graham Francis looks at how increased levels of data integrity and the shift in pharma's organizational culture impacts labeling.

It’s been widely acknowledged and accepted by leading thinkers in the pharma industry that, in comparison to other industries such as automotive and retail, it lacks the vital innovative and modern methods that are being encapsulated by the fourth industrial revolution, Industry 4.0.

It is all too common-place in the industry to see high inventories, slow responses to demand changes and stock-outs, which contribute to a high cost base and more importantly, a number of missed revenue opportunities. This is an approach which sees many of the well-established players in the industry remain stuck in the past. It is synonymous with highly risk-averse industry and shows the reluctance to move away from legacy infrastructure. However, without change, the industry will be challenged in meeting the quality risk management approach set out in ICH Q9.

What also needs to be considered is the swiftly changing workforce dynamic. Baby boomers have shaped the systems and processes that underpin drug approvals, manufacturing and distribution processes. By doing this, to a certain extent, has helped this generation protect their positions, by continuing to use legacy paper-based processes that simply don’t integrate in the web-enabled world. But this is a dated, old-fashioned approach that has fallen behind the new-age of working.

This generation of workers has extended the life of these systems and processes, through the blockbuster driven industry growth period of the late 20^th and early 21^st century. But that era is now over as we move towards much more tailor-made treatments. Another dynamic created by this environment is that it tends to foster a culture of ‘individual knowledge’ as opposed to ‘organizational knowledge’.  The pharma industry, by nature, tends to attract and retain individuals with deep levels of knowledge and expertise, sometimes at the expense of creating a more open, collaborative environment.

Global connectivity and instant communication is an essential and expected part of our everyday life. Systems such as legacy and monolithic cannot compete with predictive, intelligent web-enabled applications and are rapidly becoming unfit for purpose.

Generations Y & Z as well as Millennials are being actively targeted and employed as an attempt to develop and modernize the industry. Adopting this fresh approach will lead to new collaborative, data, social and mobile driven work practices being embraced. This however does not come without its challenges, as without the investment towards the technologies and disciplines, there is the risk that this new workforce will end up feeling isolated and unempowered.

Labeling: new processes, new mindsets

A connected workforce is of paramount importance when discussing the core of any new information-enabled enterprise. The pre-requisites for this to happen are already within our day-to-day living and working environments. We use the internet, social media, apps and mobile smartphones almost without thinking. Both consciously and unconsciously, we have already begun to embrace the modern-day technologies available to us.

Information and data are crucial to any such enterprise. But if we can’t access, manipulate, re-purpose and report on this data, it really does have limited value. This is the current situation we are in, with data being locked down in such examples as PDFs, emails and word documents.

Labeling, when considered as a business application, is no different to this.

Guidance on GxP data integrity published by the MHRA on March 9, 2018, talks about the need to design systems and processes to assure data integrity, leading to improved levels of compliance and more robust data governance.  This same data (or a subset of it) will be available for multiple purposes: research, submissions, approvals manufacturing and printing. And, with new collaborative cloud-based technologies, it can also be shared with partners, suppliers and end-users via mobile and web technologies.

We have a lot of locked-in data that needs to be released if we’re going to empower the new workforce. The benefits of doing this will stretch beyond labeling of course, but labeling is a great place to start, as it allows us to introduce new technologies and processes that can have an immediate impact on the bottom line.

This not only increases clarity as to who is the curator of the data and who has the authority to share, but also increases traceability as it becomes much easier to find where data has been used. Even if something is not right, we can understand the impact and correct it straight away.

With improved levels of data integrity, data accuracy is improved, is easier to share, and more visible for the purpose of reviewing and approving prior to it appearing on product and package labeling. But from a financial and efficiency perspective, the multi-purpose use of data lowers the risk of product recalls, has greater levels of collaboration across supply chains and increased accuracy.

Due to the data only ever existing as a single entity, this streamlines the process, rather than having multiple instances of the data shared across different documents, emails, PDFs and spreadsheets, with no clear ownership.

Potentially, staff turnover will also be reduced as the workforce can crossover skills from their personal lives into the workplace. This would look to re-energize the workplace and revitalize other functions. Departments will be able to see what can be done with business benefits becoming visible through transparent reporting.

By embracing better quality risk management, increased levels of data integrity and a shift in organizational culture, the pharma industry will be much better positioned not only to respond effectively to new legislation, but to build a sustainable business in the new area of patient-centric medicine. Simplified systems and processes will bring new levels of transparency to labeling and artwork leading to reduced risk of non-compliance through an increasingly engaged and motivated workforce.

Graham Francis is Product Marketing Manager at Kallik.