There is an ever-growing quantity of content that needs to fit on prescription and over-the-counter drug labels. Pharma manufacturers today must account for constantly changing regional and regulatory requirements as well as labeling standards set by customers and suppliers, all of which further compounds challenges like lengthy approval processes and increasing pressure to improve the speed of operations. And adding to this, labeling errors can cause costly fines and recalls that badly damage established and up-and-coming brands alike.
As labels evolve and more is demanded of pharma manufacturers, label management methods need to become more organized, efficient and take advantage of the latest technology. Just as a pharma CTO may work to ensure their enterprise resource planning (ERP) or warehouse management systems (WMS) are in sync, companies need to make sure their labeling is harmonized at the enterprise-wide level as well. Otherwise, the challenges above won’t only be a headache, but potentially ruinous and dangerous.
The risks of “siloed” labeling
The days of different distribution centers and production facilities managing labels in isolation, with varying software apps, manually inputted data or constantly changing “as-needed” solutions, are coming to an end for good reason. These siloed approaches are wildly inefficient and costly, cause an inability to scale operations swiftly, add expenses from having to upgrade and support multiple applications, delay responses to customer requirements, present risks of non-compliance fines, and ultimately, create consumer health dangers if pharma products are mislabeled.
While labeling must be efficient across industries, the highly regulated nature of the life sciences industry requires a higher standard. For instance, in the pharma industry, it’s important for manufacturers to be able to access the same consistent, approved content for labels. Additionally, every time a label change is made it must be put through a rigorous quality process. Failing to do so could result in errors that translate into penalties and delays.
By taking steps to address labeling on the enterprise-wide level, organizations can ensure their labels are commonly accessible and accurate, with a single source of truth for label data. They can also future-proof their processes, making it easier for pharma companies to scale labeling without needing to manage re-validation and significant hurdles in meeting compliance for each new facility.
Eliminating costs and unnecessary stoppages
Pharma manufacturers today are facing a wave of competitive pressures, such as products coming off patent, changing market pricing, and new requirements from regulators and governments. Facing these pressures means organizations must streamline more and cut costs. Labeling is one area where this can be done for many.
Labeling issues, like incorrect or missing data for instance, often delay shipping and lead to lost revenue. Errors commonly occur when manufacturers must maintain many different labeling solutions that have no connectivity to ensure key data is accurate. Localized or disparate data not only means more redundant work, but also an increased chance of human error, especially when manufacturers may need to consider elements like multi-lingual copy requirements or different regulations. This is where an enterprise-wide approach can help, as it can enable capabilities like standardized and version-controlled translation management that ensure accurate labeling on a global scale.
Other benefits of taking an enterprise-wide approach to labeling include integrating it with critical applications, like WMS, ERP or product lifecycle management (PLM) systems. By deploying this integration, manufacturers can ensure information used for labeling draws on an enterprise’s established sources of truth and reservoirs of useful data. This can eliminate key inefficiencies, like an over reliance on manual spreadsheets or other disparate data systems.
Streamlining label approvals and design
Approval and design cycles for pallet, carton and product labels may require custom coding, which means waiting for IT resources to become available. Commonly, different work groups, from manufacturing to operations to IT, also have to provide oversight and input into labeling. Involving this many stakeholders can mean it takes months to gain final approval for only one label.
Using an enterprise-wide approach can make this process simpler and faster. For instance, certain browser-based design options provide multi-language support capabilities, a catalog of barcode symbols and other advanced workflow tools that make the design, review and approval of labels easier. This means that after an initial label process is rolled out, business users of varying skill levels can then manage the process and make independent changes. This can eliminate many technical difficulties or hold-ups that beleaguer approval processes.
Ending version control nightmares and inefficient updates
Due to customer demands and regional, language and regulatory requirements, continual label updates are inevitable. Without a standardized Enterprise Labeling system, updates are often made in isolation, with a separate, unique template for each one. This adds the extra burden of maintaining potentially thousands of different labels, and it means even simple alterations, like a brand or logo change, can cause a massive administrative burden or errors.
An enterprise-wide approach to labeling can reduce labeling variability and ensure organizations don’t have to create separate templates for every update. Some systems can even apply data-driven business logic and enable automated updates that can be managed by business users without IT assistance.
In many cases, an enterprise approach means label updates can be managed proactively in one central location as opposed to reactively at local sites. Updated info from other enterprise systems can automatically carry over to labels if the proper integration is in place. This means a simple updated address in the ERP system, for instance, could replace spending countless hours spent changing different label templates.
Rapid scalability for expansion
Many pharma manufacturers manage multiple sites across geographies and want to expand to new regions. If labeling is not considered from a unified, enterprise-wide viewpoint, these expansions could require the purchase of excess servers and licenses, which often means an overly protracted period for negotiations and procurement. This also means extra IT time and resources may be needed to install, update and maintain separate instances of the same software at different locations. This also brings an ongoing challenge of ensuring each location is following an enterprise’s overall standards and guidelines, as a silo will have been created.
One of the easiest methods to make rolling out a standardized, enterprise-wide labeling system simpler is to use a solution that is based in the cloud. With a cloud-based Enterprise Labeling solution, organizations can quickly add new users and remote locations, without worrying about additional licenses, services or equipment. The cloud can also readily connect a new site with an enterprise’s corporate data, look and feel, as well as the pertinent product and client information that may have not been integrated yet. Even if you’re working with a third-party supplier, you could readily extend compliant, controlled labeling to their operations as well for seamless remote collaboration.
Reduce remote label delivery costs
Many organizations have standardized on a labeling solution, but the solution is only installed at one location. In this scenario, all labels are printed at this single site and then shipped to remote locations and/or business partner sites. While this approach can help maintain quality control, it also presents inventory challenges and multiplies the number of label shipments, meaning more transportation costs and shipping delays, as well as added risks from a lack of control, stolen labels, the black market and more. And with sustainability being top of mind for many organizations, unexpected label changes can result in excess waste.
By using an enterprise-wide labeling approach, organizations can provide remote printing capabilities and extended role-based access. This ensures labels being used are compliant and approved, and it eliminates extra costs associated with regularly shipping labels to remote sites.
Efficiently meeting compliance and extending distribution
Non-compliance could mean shipments are refused by customers, held or turned back at border crossings. It may also mean substantial fines, or even a danger to consumers. An enterprise-wide approach can help avoid these risks. One way this approach can address meeting compliance is by integrating labeling with business applications. This can help organizations make updates based on regulations in one place, which will serve as a reliable source of truth and immediately impact labels across the enterprise.
Enterprise Labeling solutions can also help pharma manufacturers agilely and easily respond to sudden changes, as these solutions can make it easier for various types of users from any location to design labels that are compliant with industry regulations and customer requests. Certain label management systems can also be easily extended to each distribution location in a global supply chain — ensuring a coordinated effort from upstream where raw materials are handled, to downstream where finished goods are being shipped.
Additionally, an enterprise-wide solution can make tracking labels easier. For instance, some solutions feature a centralized print history. This capability can enable easily followable audit trails with a searchable detailed record, showing where and by whom a label was originated, changed and printed.
Eliminating expenses from relabeling
Disparate approaches between manufacturers and their third-party business partners often means more relabeling. Month to month, many manufacturers across the globe use a large number of resources to relabel inbound materials before they move them to inventory or production. During this time, pallets of supplier goods can stack up in receiving, where they take up space and wait to be sorted. As a consequence, companies may need to then maintain a buffer inventory. Adding to this, incorrect receipts can contain miscalculated shipment info, causing a shortage or excess of parts on hand, or there could be a major hold-up from mislabeling.
Helping to ease this burden, an enterprise-wide solution can often be shared via the cloud or other means. This means an enterprise’s way of labeling can be easily and securely extended to suppliers, third-party logistics providers and other trusted partners. This greatly eliminates relabeling as well as operational expenses from hiring re-labelers and capital expenditures from extra storage and inventory costs. It can also reduce production line delays.
A growing opportunity for all pharma manufacturers
Labeling has always been mission-critical, but too often it’s been overlooked from an enterprise-wide perspective. This oversight is becoming increasingly unsustainable for pharmaceutical manufacturers, who want to keep up with rising expectations from consumers, governments, partners and other stakeholders.
But rather than thinking of this as simply a challenge, there are many new opportunities for pharma manufacturers. With technologies like the cloud, companies of any size can now adopt an enterprise solution for labeling to achieve compliance, improve accuracy, automate label management, drive operational efficiencies and keep costs down.