Pharma and Medical Device Technology Is Transforming Labeling and Packaging Review
The pharmaceutical and medical device sectors are undergoing significant transformation. Faced with growing regulatory demands, the rapid pace of globalization, and higher market expectations, the pressure to deliver safe, effective products faster and more efficiently is now greater than ever before.Adopting and efficiently integrating technologies is no longer simply a choice or one strategy among many – it is essential for quality, speed and compliance. Here we explore pharma industry technology trends, med device technology adoption and process automation in depth, focusing on three key areas: integration, automation and cloud readiness.
Why operational efficiency matters more than ever
Pharma and medical device industries are at the sharp end when it comes to meeting the challenges of pharma process efficiency, pharma digital transformation (e.g., with the adoption of e-labeling), and medical device labeling compliance.Challenges faced by medical device companies, for instance, range from regulatory change itself (e.g., due to the alignment of US quality system regulations with ISO standards) to managing labeling consistency across different jurisdictions. (We go into this in detail
here)
. Pharma and medical device companies are also confronted by:
- Pressure of accelerated time-to-market
- Increased number of stockkeeping units (SKUs), along with the need for localized packaging for multi-market submissions
- Manual processes that are not scalable, leading to compliance risks and bottlenecks
Shift from desktop software to cloud technologies
Historically, pharma and medical device companies have favored desktop and on-premise software. These platforms offered the control, security, and validation required in order to comply with 21 CFR Part 11 in the US, and Good Manufacturing Practice guidelines (Annex 11) in the European Union (EU). [https://learn.microsoft.com/en-us/azure/compliance/offerings/offering-gxp]However, we are rapidly witnessing a pharma cloud migration, with highly efficient cloud technologies that now meet and exceed industry standards for data integrity, validation, privacy and security.With the growth of remote workplaces and even greater collaboration across global teams, cloud platforms offer the more-efficient solution. This is especially because of a high degree of scalability and flexibility.Pharma technology modernization is extending across many different tasks, including document management, labeling, and packaging review. And regulatory bodies are backing this modernization. One example is the FDA’s Case for Quality initiative (CfQ), which encourages the use of digital tools, automation, and real-time monitoring to encourage medical device manufacturers to reach best-in-class levels of industry peers. A further feature of the sector today is the growth of software as a medical device (SaMD), and medical device cloud software – essentially, distributing the software (itself a medical device or supporting a device) via the cloud.
Integration and automation are critical drivers for success
Taking into consideration the larger number of SKUs, a trend toward tailored patient-centric e-labeling, coupled with the need to be able to upscale quickly and flexibly, manual processes and poorly integrated workflows are simply too inefficient. Modern labeling and packaging processes demand integrated workflows and tools that work efficiently across different parts of an organization and its platforms. In practice, this means being able to integrate the different information management and workflow systems into one seamless, holistic core. Examples of systems that might be integrated are Artwork Management Systems (AMS), Regulatory Information Management (RIM) platforms, and Document Management Systems (DMS).Mike Baird, Director of Product Management at Schlafender Hase, explains. “Everything speaks for integrated systems today. They reduce the amount of manual data entry and eliminate duplicate tasks. This reduces cycle times, and reviews can be carried out earlier in the workflow. You can avoid errors in labeling and packaging before they snowball into costly reworking, further review rounds, late-stage revisions, and so on. With the pressure to get to market quickly and maximize return on investment, you of course want to tackle the root causes of delays, especially for new products requiring regulatory submission and approval.” The trend, he adds, is clearly towards interoperability – the ability of systems to communicate and exchange data – through application protocol interfaces, or APIs, which are a set of rules providing the framework for communication and exchange.We might see this in terms of three interdependent elements. The first is capitalizing on efficiencies by taking a connected approach to processes and workflows within the organization. For example, that might be the review and verification of labeling, including text, barcodes and artwork such as logos, integrated into larger workflows.Secondly, it means the communication and exchange of information with regulatory bodies like the FDA or European Medicines Agency. The dunes of this regulatory landscape are shifting quietly but steadily. (See our article FHIR
here).Thirdly, it means seamlessly integrating patients into this technological cosmos. “E-labeling is already a fact of life in pharma jurisdictions like Singapore and Japan, and North American and European bodies have initiatives in place to build on e-labeling,” says Mike Baird. He points to things like patients being able to call up healthcare records on mobile devices, or smartwatches monitoring health itself and sharing this information with other devices. “Labeling itself is taking a hybrid form,” he adds. “Companies need to be able to manage physical and electronic labeling in one automated process.”
How companies are future-proofing their labeling and packaging workflows
To future-proof pharma workflows, life sciences companies are investing in centralized content management on cloud-ready platforms. These promote collaborative, transparent workflows between teams such as regulatory affairs, marketing, and legal. The platforms support real-time updates and can be scaled to accommodate new products, languages, and markets — all while maintaining control and compliance.Just one example of how a team can benefit is in the development and management of promotional materials. This requires input from a range of corporate functions brought together in cross-functional groups that often work remotely from each other. Typically, promotional material requires skills sets ranging from marketing through to medical, legal and regulatory (MLR) expertise brought together in a Promotion Advertising Review Committee (PARC). (See our article on this
here).Furthermore, as mentioned earlier, workflows must seamlessly to integrate medical device digital labeling, ensuring that electronic and physical labeling is consistent and compliant.
How TVT is evolving to meet industry needs
TVT and its add-on modules TVT Artwork, TVT Barcode and TVT Spelling automate the proofreading and verification processes in labeling and packaging. TVT has been promoting compliance in regulated industries for over two decades. It can compare e-labeling content such as documents in HTML format generated from XML, the accepted standard for e-labeling, with any digital document (e.g., PDF or Word format) and immediately detect deviations and errors. Coupled with barcode verification and grading, this is a comprehensive, future-proof solution for the e-labeling environment. Furthermore, it can also be integrated into any information management system (e.g., Artwork Management System) and workflow, meeting the requirements of automated and integrated workflows.Recognizing the industry’s need for more flexible, scalable review solutions, TVT is excited to be launching soon an updated cloud version – designed to bring the same pharma-grade proofing trusted for years to a new, fully cloud-based environment. Key benefits are:
- Real-time collaboration across departments and geographies
- Seamless integration
- Validation and compliance tools, now with cloud scalability
Meeting the moment through technology adoption
“Automation and integration, not manual processes in silos, are only the way ahead,” says Mike Baird, and the industry is agreeing with him as it moves to cloud-based approaches and adopting technologies in this drive to automate and integrate. “We see our TVT cloud software, TVT Integration and the pharma labeling cloud solution as a whole as the way for companies to position themselves in future for faster launches, for lowering compliance risks, and for strengthening their global competitiveness.”
