Serialization is much more than a rule to be obeyed – it’s a huge opportunity
Global pharma is teetering on the brink of a new world in which ground-breaking regulations impose strict serialization, traceability and verification obligations on the medicine supply chain. With deadlines for the adoption of DSCSA and FMD imminent it’s no surprise that companies are ramping up their efforts to assure regulatory compliance. Many businesses are adopting compliance-first (or indeed compliance-only) approaches that concentrate solely on ensuring they do the bare minimum to meet regulatory requirements. They’re ticking a box. The most proactive companies, however, have taken a different approach: they’re not ticking the box, they’re thinking outside of it – by focusing on quality and long-term value. It’s the right way to go. Here’s why.
Serialization is much more than a rule to be obeyed – it’s a huge opportunity for industry. But the possibilities will only emerge through a focus on quality right from the outset.
Key constituents of quality
Key to an effective serialization strategy is good technology, therefore the right partner and the best software is critical to success. However, the design, configuration and implementation of a system will ultimately be the difference between an approach that’s content with compliance and one that’s striving for added-value far beyond it.
The key phases of the adoption life-cycle typically include:
- Defining requirements
This requires robust insight into regulatory requirements, the holistic needs of the market and, later in the development curve, the specific business needs of individual organizations. Clearly defined requirements outline the scope of the opportunity and provide the baseline for your approach. Getting them right is imperative.
- Designing a solution
The development of core software requires continuous collaboration with a broad set of stakeholders to ensure the solution marries regulatory needs with recognizable industry processes and unique business characteristics. It also requires a full appreciation of the nuances of the medicine supply chain. It’s an iterative process.
- Characterizing processes
Process characterization is an essential component of a quality-first approach. Stakeholders must have a deep understanding of the solution, how it operates and the areas where it may break. Only by understanding how individual components interact with each-other is it possible to build an optimal system where everyone has confidence in the data.
- Validating processes
Hand-in-hand with characterization, achieving data quality requires robust validation of the processes established in the characterization phase. The best systems adopt ISPE’s GAMP 5 guidance for validation as a minimum.
Quality-led systems build in automated, ‘always on’ monitoring so that organizations can detect and respond to problems or anomalies quickly and effectively.
Success is ultimately contingent upon having an effective change control system that allows companies to modify and maintain the quality of both the processes and the data within the system. Fundamentally, serialization depends on having accurate, secure and accessible data – as well as appropriate processes that can reliably and transparently accommodate change.
The long-term advantages of serialization extend far beyond satisfying regulations. Serialization naturally introduces traceability to the medicine supply chain, but could also be used to provide added value for pharma, providers and, crucially, patients. From a patient safety perspective, in addition to providing reassurance around the authenticity of medicines, it can help also accelerate and improve the granularity of product recalls – benefitting wholesalers, pharmacists and patients.
This powerful data can inform marketing strategy, improve patient support and stimulate patient-centred innovation.
A quality ambition
Ultimately, the success of your serialization efforts all comes down to ambition. The long-term, quality-first approach is underscored by a profound logic: compliance is a natural by-product of quality-driven objectives, but the reverse is seldom true. If the limit of your ambition is compliance, you may never achieve a quality solution. But if you’re unwavering focus is on quality… you’ll always be compliant. That’s why, when it comes to serialization, it makes sense not to just tick the box, but to think outside of it. Aim for quality – and you’ll be a serial winner.
rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.