Frank Hessler, Managing Director
The Pharmaceutical Packaging and Labelling market is experiencing steady growth and is expected to achieve a global market worth of $78.79 billion by 2020. However, pharmaceutical companies are currently facing a number of packaging and labelling challenges, including regulatory change, increasingly globalised supply chains, multilingual packaging and labelling, and the growth of adherence packaging. Furthermore, a safe and effective pharma product that can’t be produced efficiently is at a competitive disadvantage and is ultimately not a successful product.
These challenges place a sharp focus on labelling and packaging and demand highly efficient packaging and labelling verification solutions. Frank Hessler, Managing Director of Schlafender Hase, explains: “Schlafender Hase develops advanced verification technologies for the pharma and medical device industry because it’s crucial for the industry to achieve accuracy, quality, and compliance in labelling and packaging.” Hessler’s company is the leader in providing intelligent automated proofreading software and services for regulated industries. Schlafender Hase’s TVT®, the Text Verification Tool®, helps pharma companies ensure a compliant, error-free, and consistent labelling process.
“Pharma labels are not just important for patients to learn about the specific formulations of a product, but also serve to identify, protect, and inform the patient on how to use them safely, and effectively,” says Regional Sales Director of Schlafender Hase, Marc Chaillou. At this juncture, one of the key challenges for pharma companies is aligning drug prescription instructions with regulatory requirements and additional language translations for a label.
Schlafender Hase develops advanced verification technologies for the pharma and medical device industry to help them achieve accuracy, quality, and compliance in labelling and packaging
Schlafender Hase’s TVT makes it simple to quickly and accurately proofread the most complicated documents. From the technology standpoint, TVT is state of the art. It efficiently inspects documents by matching and comparing Unicode values character by character. It documents all actions and reviews performed by users, including any annotations in a report to provide a fully compliant audit trail. The report can be saved as a PDF, XML, HTML file, or printed for future reference. Using just a single tool, pharma companies are able to accurately proofread text in different layouts, file formats, tables, multi-lingual documents (including Braille and right-to-left languages), images, and full-page artwork. With TVT in place, companies can avoid expensive reprints, reduce recalls, and increase patient safety. No other industry in the world is more highly regulated with respect to product safety – and with good reason. That means all information produced in the packaging process – inserts, IFUs, labels, cartons, all parts – must be 100 percent error-free. It is also important to recognize that Pharma is a business, and to be successful as a business, it must avoid things like expensive recalls by having processes that are not just accurate but also efficient. To be competitive in today’s markets, pharma companies must increase productivity without always being able to increase the workforce. “TVT mirrors the industry’s needs. It ensures the accuracy needed to meet compliance requirements and streamlines the entire proofreading workflow without compromising safety and quality,” explains Hessler.
Since the company’s founding in 2001, Schlafender Hase’s craftsmanship and attention to detail on the software engineering side has been backed by its commitment to quality and customer feedback. The company’s developers work with the Scrum framework and Microsoft Azure DevOps Server. The software development process includes specification of functions and stepwise implementation with rigorous testing and full traceability at each step. This ensures the quality of updates. Furthermore, experts at Schlafender Hase provide best practices guidance to customers on how to integrate TVT into workflows – large or small.
Schlafender Hase works with the major pharma companies throughout the world, as well as with smaller players, to provide effective verification solutions. One case in point is the research-based pharmaceutical company Pharmathen, headquartered in Greece. Faced with the challenge of tight deadlines and implementing regulatory changes, even the highly seasoned team of professional proofreaders at Pharmathen found that reviewing materials for punctuation as well as stylistic formatting details was extremely time-consuming and error-prone. Pharmathen identified the tedious process of proofreading as the bottleneck and sought a tool that would assist their team in alleviating the need for manual proofreading. By doing so, Pharmathen sought to increase the accuracy, safety, and compliance of its labelling and packaging, as well as the satisfaction of employees. The results were immediate. With TVT in place, approval cycles took one day instead of three, and Pharmathen employees could be more confident in the accuracy of their work. They were able to work more efficiently, save time, and reduce stress. Backed by its impressive track record, Schlafender Hase is currently working on integrating AI into the future releases. Current users will be able to upgrade to the new release. The next update of TVT, Frank Hessler explains, will include greater integration of Web API and graphic support as a whole.