A U.S.-based pharmaceutical company with 25,000 employees worldwide and approximately $20 billion in revenue was looking to create a central repository for its labeling content. The goal was to have one, authoritative source for its worldwide labeling—a system capable of tracking changes from the Core Data Sheet to local labeling documents, and of generating Structured Product Labeling (SPL) files directly from the labeling content without having to go through manual conversion. After looking at software from various vendors and going through an extensive search process, the company chose Glemser’s xmLabeling solutions.


Pharmaceutical companies spend a significant amount of time and energy organizing product-labeling documents such as U.S. Package Inserts, Summaries of Product Characteristics and Core Data Sheets. The information is published to product websites and included in final product packages. It’s an enormous task to manage and coordinate this body of information across all markets. At the same time, pharmaceutical companies must support multiple labeling business processes and regulatory requirements. These processes and their submission parameters can vary widely, depending upon where in the world a company is doing business. For example, in the United States the Food and Drug Administration (FDA) requires that companies submit labeling content annually. In addition, if content is updated during the year, and depending on the change’s impact, requirements could warrant submission in advance of the label content changes or at the time of the changes. In either case, the FDA mandates that companies submit labeling content electronically in a specific way—in an XML format called Structured Product Labeling (SPL). Meanwhile, the European Medicines Agency (EMA) allows companies to submit labeling content via centralized, decentralized, mutual recognition, or national submission procedures. Whichever path is chosen, however, companies must submit European labeling content in Microsoft Word in accordance with Quality Review of Documents (QRD) guidelines. As a result of these constraints, information is often repeated over and over again for various documents for different formulations, strengths and presentations. If efforts are not effectively coordinated, the result is the creation of multiple, nearly identical master versions that become unwieldy to update and track. Worse still, it can create inaccurate labeling documents potentially resulting in the recall of batches of pharmaceutical products. The pharmaceutical company in question was dealing with such document generation and tracking issues on a daily basis. Its labeling content was kept in multiple repositories worldwide. With 25,000 employees and distribution in more than 170 countries, duplication was rampant and tracking documents for accuracy and compliance was difficult to manage effectively. Labeling content was created and updated in a Microsoft Word document that was that was then cut and pasted into an SPL document—creating two documents. To satisfy the different formulations, strengths, presentations and any additional tweaks needed for each market, nearly identical documents were created.

The company could end up with 50 or more labels for one drug. While it was laborious to create the first time, it became a nightmare whenever updates were needed. Ensuring all labels had the correct changes meant hours of tedious, painstaking proofreading. Adding to the duplication and tracking conundrum was the fact that individuals at the company kept labels on their personal computers and laptops. Although new versions of labels were tracked in an Excel Spreadsheet, it was difficult for the Labeling Author to know for certain what information was the most recent or the most accurate. Was it the original word document with its edits, or the SPL file? Tracking and duplication also created disconnects between the company’s Core Data Sheets and local labels. Local country labels were housed in each individual country of ce, and not always uploaded to headquarters in a timely manner. There was no guarantee that what was being housed at headquarters was the most up-to-date version.

“The technology and Glemser staff bridge Regulatory and IT professionals, so that we can quickly adapt to changes in international regulations.”

– Manager, R&D IT Risk and Compliance


To make its labeling processes more manageable, ensure accuracy and employ tighter control, the company decided to implement xmLabeling through Glemser Technologies. xmLabeling is a proven, comprehensive application for effectively managing global labeling content and related processes. It handles (among other requirements) SPL, content fragment linking and re-use, translation management, automatic generation of submissible content that complies with the latest SPL standard and QRD guidelines, regulatory compliance and tracking, and Word-like editing with revision tracking. Glemser, with more than 27 years of practical business knowledge, drew on its extensive, in-depth experience implementing large-scale, IT solutions for global companies to successfully execute the implementation of the new xmLabeling system.

Today, the company in question has a single repository for its labeling content, and a single authoritative source for each label. Everything is in one place. A Master XML File is rendered in MS Word, which is automatically sent to the website and into an SPL file. Versions of each label are now controlled—employees check out labeling content from the single repository, and check it back in when they are nished. Duplication is eliminated, and changes are only made to this single, authoritative source. In addition, the company is also able to track changes to its Core Data Sheets all the way through to local labels, ensuring all individual country offices have the same information.


The switch to xmLabeling has improved compliance and reduced risk while also improving efficiency and reducing costs. “The xmLabeling and xmRender products have helped us achieve uniform and compliant processes for our complex global pharmaceutical labeling operations,” said the company’s manager for R&D IT Risk and Compliance.

For the company’s Regulatory Operations division, compliance is easier to manage. All regulatory assets are in a central place—easily controlled while also allowing for seamless integration with other regulatory requirements. For example, in the past when an auditor requested documentation, it could take up to a month to supply the necessary materials. Now, it takes a few hours. Plus, Regulatory Operations is able to supply comprehensive tracking documentation proving the company met all requirements and followed all procedures properly.

For the company’s Labeling Strategists and Labeling Authors, there is reduced complexity and increased efficiency in coordinating the Core Data Sheets. Because the company manages a single set of labeling content, the Labeling Strategist or Author no longer needs to manually cut and paste information, but can easily re-use core components, saving time and effort and reducing costs. The Labeling Author can easily track changes to Core Data Sheets. For example, local country offices are notified of changes to the data sheet, and changes to local labels are tracked against updated data sheets. Labeling content is no longer kept on individual computers or laptops, but checked in and out from the central server.

Finally, the centralized, controlled system powered by xmLabeling has increased accuracy and asset management across the board. This in turn has given the company the ability to make better, more accurate, business decisions because it is working with up-to-date information. The company can better predict, for example, the number of labels it will need, and can forecast future needs more easily. “The technology and Glemser staff bridge Regulatory and IT professionals, so that we can quickly adapt to changes in international regulations,” the company’s manager said.