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Each year, new regulations come into place and the existing ones continue to tighten. As a result, organizations in highly regulated industries require high levels of quality assurance throughout their entire labeling and artwork process, yet very few are able to maintain a well-managed process from start to finish. Most companies continue to neglect the important final segment of the labeling process: printing, opting for manual processes that leave this stage vulnerable to countless errors. So, how can highly regulated industries optimize their factory printing process to avoid falling at the final hurdle?


The complex labeling and artwork process


One of the struggles experienced by companies in highly regulated industries is the complex multi-layered packaging and distribution process of products. For example, two or more individual products packaged together may constitute a ‘kit’, which requires its own unique device identifier (UDI). These same products may also be sold individually, requiring a separate UDI for these instances. When factory print solutions are disconnected from the rest of the process, there is a heavy reliance on the knowledge of the print operators to ensure that the correct label is applied to both the packaging of the kit as well as its individual components. This process has to be repeated for the inner label, outer label, box label, carton label and patient label, making it incredibly easy to mix them up, as well as being a lengthy process. Manually identifying the correct label leaves great margins for human error, even amongst the most skilled and experienced operators. Reliance on emails, printed documents and other uncontrolled forms of communication not only leads to oversight and errors, but also makes it incredibly difficult to demonstrate a clear audit trail underpinning proof of compliance. 


The consequences of doing it wrong


Despite efforts to maintain high levels of quality control, errors still occur. This is primarily due to the fact that, in most organizations, factory printing is generally a manual rather than an automated process. Even when mistakes are rare, in such high-stakes industries, every mistake matters. The consequences of getting it wrong are significant, for both the organization and the end-user. A labeling error such as the incorrect dosage information on the instructions for use of pharmaceutical products or medical devices can lead to a patient injury or even be fatal. The result of manual processes is often an increased likelihood of these types of errors and subsequently recalls. It is reported that labeling and packaging mistakes account for between 35% and 40% of all errors seen by the FDA. These are not only costly, but also damaging to a company’s share prices, reputation and public confidence.


The disconnection between the upstream label approval process and the downstream printing process leaves labeling projects prone to errors that could be completely avoided by an intelligent, end-to-end system. A print operator manually mistyping a batch number or an expiry date by just one incorrect character can have a major impact. Similarly, patient specific products can require an input of up to 50 digits by the print operator to generate the correct label, and one error can lead to the wrong label or the wrong information being used. These risks are unnecessary. Connected systems can simply calculate and populate these details automatically, removing the chances of such errors occurring. 


How can your organization optimize the factory printing process and minimize errors?


It is clear that the ideal solution is therefore an automated factory printing process, where the operator follows a set workflow and the only choice they need to make is what task to complete next. It is a powerful competitive advantage to have a tool specifically designed to tackle the many challenges presented by strict, ever-changing regulations. A centralized solution that connects the process from artwork creation to factory printing provides numerous benefits to organizations, including  reduced risk of errors, proving compliance and accelerating speed to market. 


The benefits that an end-to-end labeling and artwork management software can provide to organizations in highly regulated industries do not stop here. For more information on the benefits of ditching manual processes when it comes to factory printing, you can read our recent white paper. This explores the risks of a disconnected system in further detail,  as well as explaining what an automated labeling and artwork management software actually is, what it means to have one implemented and how it can give your company a strong competitive advantage.


To learn more about how Kallik can help your business to optimize its factory printing process, you can get in touch with us at

Bob Tilling