Switch to xmLabeling Leads to Big Rewards

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.

Challenges

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

Solution

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.

Results

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.


Leading Global Healthcare Company Determines Manual Processes Pose High Risk for Non-compliant Clinical Labeling Content

Implementation of Glemser xmCLDS system provides automated, validated alternative that ensures accuracy and compliance

Following an analysis of deviations within its Label Definition Contract and Regulatory Rules, a leading global healthcare company—provider of pharmaceuticals, vaccines, and consumer healthcare—determined its in-house application for clinical labeling to be a high compliance risk. Its onerous, manual process was prone to human error and misinterpretation leading to incorrect or incomplete label information.

Challenge

Industry-wide, regulatory authorities have demonstrated increased focus on data integrity. Beyond the need to meet and exceed regulatory standards, non-compliant labeling will likely invalidate a study, could lead to product recalls costing millions, or adversely a ect the patient. Study delays may give competitors the ability to be “ first to file” along with the advantages that affords. Non-compliance can also signi cantly damage a company’s credibility and reputation.

Beyond the elements of a label—protocol number, batch number, drug name and strength, directions for use, storage conditions, and caution statements—each label must also correspond to type of study (i.e. single blind, double blind), package type (i.e. bottle, vial), and where the trial takes place. All of these variables require different elements to be present on a label, potentially translated into different languages. All elements must also meet Health Authority and local country-based requirements. It is this variability that makes the manual application of clinical labeling rules so complex and vulnerable to non-compliance.

In this case, Good Manufacturing Practice (GMP) deviations were attributed to the burden of manually maintaining the record, reliance on manual change noti cations, and lacking information veri cation. Seeking an automated and validated alternative to its manual, paper-based system, the company engaged Glemser to implement a clinical labeling solution that would not only minimize risk and exceed regulatory expectations, but also to enable it to con dently demonstrate control during audits.

Solution

Glemser’s Clinical Label Development System (xmCLDS) manages regulated content through all stages of the document’s lifecycle to reduces the potential for human error as well as label creation time. The xmCLDS system is built on Documentum’s architecture to provide enhanced functionality required to enable authorized users to manage content in XML format. The xmCLDS system consists of two components: an authoring component and a Document Management System (DMS) component.

The authoring component enables the user to easily author phrases and study data. The system utilizes a library of approved phrases and a business rules engine to prede ne a set of phrases required for a label based on information such as country, label type and package type, as well as a set of prede ned questions. The label is initially created in English then, once approved, generated into all required languages based on the phrase translations stored within the system.

The DMS component manages content translations, relationships, version control, lifecycles, review and approval work ows, system noti cations, tracking and reporting, audit trail, and security. Authorized users can manage the phrase library and business rules as needed in order to accommodate changing regulatory requirements and business processes. Change control is built into xmCLDS and will ensure that processes are followed before making any changes to approved content.

Benefits

xmCLDS is a validated system, thus ensuring accuracy and compliance. Its automated components remove paper and enforce business rules through work ow helping the client to compliantly manage rules, phrases, translations and label content. xmCLDS then stores and manages client data in a way that is easy to access and report. This signi cantly enhances operational compliance and data integrity in client supply chain facilities. Data is reliable, complete, consistent, accurate, and secure throughout the data lifecycle.


Leveraging Web Content Management to Accelerate Marketing Collateral and Product Time-to-Market

“The client needed advanced Web-based workflow capabilities. Using the Documentum content management platform, we have streamlined our collaborative marketing materials creation and review process, enabling us to deliver products to market faster and more effectively.”

Business Overview

The client, a worldwide pharmaceutical company committed to discovering, developing, and marketing new therapies and treatment programs that can improve people's health and save lives. The company is a recognized leader in biotechnology, genomics, and gene therapy.

Their core product groups are allergy/respiratory, anti-infective/anticancer, dermatologicals, and cardiovasculars. The company also has a global animal health business as well as leading consumer brands of foot care, over-the-counter, and sun care products.

Innovative research, effective marketing, and solid financial management have enabled the client to grow and deliver superior financial results year after year.

Challenges

With worldwide research and manufacturing facilities, the client's product marketing team is responsible for coordinating communications and advertising efforts with the company’s various internal and external constituencies, the latter of which includes doctors, regulatory officials, hospital administrators, pharmacists, ad agencies, and legal staff.

Given the competitiveness of the global pharmaceutical industry and the rush to market new products, the importance of the product marketing group cannot be underestimated. The division is the lifeline between the client’s products and the doctors, pharmacists, and the general consumers who must feel comfortable with client branded treatments.

“All the material we publish to the Web and otherwise has to go through a lengthy approval process, involving five separate departments ... as well as outside agencies that collaborate with us on the projects,” says the Director of Marketing Services. “Each week 14 people would meet for one-half day to make critical decisions about the projects underway. It was very time intensive.”

Automate Marketing Collateral Cycle to Accelerate Creation of Powerful Sales Tools

The product marketing group produces several pieces of collateral, such as sales literature and data sheets, for each pharmaceutical taken to market. The creation, review, and approval of these materials was an entirely manual process and the company had no means of knowing the points collateral pieces were at within it.

The client recognized that, in order to arm its sales force with marketing collateral in a more timely fashion, it would need to shorten this process by leveraging the Web.

Minimize In-Person Meetings for Increased Time-to-Market and ROI

For all projects, the client involved outside agencies as well as its staff worldwide. Such an inclusive process, although it resulted in the most powerful marketing materials, was extremely time-consuming. The product marketing team as well as outside agencies would meet in person frequently to complete the materials.

The company realized that it required a more efficient way of managing its external partners as well as five of its departments in the marketing collateral creation, review, and approval process. Minimizing in-person meetings, for example, would help to streamline the process and accelerate the time-to-market of products and collateral.

 

Documentum Solution

The client realized the urgent need for advanced workflow and content management functionality via the Web. The company, a long-term customer of Documentum, decided to implement the Documentum 4i eBusiness Platform company-wide. As part of this process, the client transitioned its marketing materials application to the Web-based Documentum solution.

Automated Workflow Reduced Collateral Cycle by 35 Percent

The client has replaced the manual review and approval process with automated workflow processes.

Because the Documentum product supports open standards, the client was able to develop its own custom application to meet its specific workflow requirements. The application creates an audit trail for content as they move through the lifecycle model. As a result, the company has improved visibility of the status of each collateral piece. This eliminates lag-time during review and expedites the approval process through the legal, research, creative, and marketing departments.

“I am continually impressed by the audit function,” says the client's Marketing Manager. “We can better manage each piece, see where a bottleneck is, and move quickly to solve the problem. We have better accountability. Documentum has compressed turnaround time from creation to publication from weeks to days,” she explains.

Collaboration Via Web Cut Meeting Time by 75 Percent

Building a mirrored repository that is replicated allows outside agencies to access critical information via a Web-browser. As a result, face-to-face meetings are no longer as necessary. The Documentum solution has cut the overall meeting time by 75 percent, ultimately enhancing the client’s bottom line.

 

Summary

With the Documentum Web-based content management solution and  its automated business process and workflow component—the client has reduced time-consuming in-person meetings. The company has accelerated the creation, review, and approval of its marketing collateral, and can now track the status of all of its collateral pieces in the life cycle. As a result, marketing collateral and products reach the market more quickly and efficiently.


Content Management Case Study (Testing Specifications)

Executive Summary

This case study presents a project in which Glemser Technologies analyzed, simplified, and solved their client’s highly technical, multifaceted problem. This included issues related to test specifications, analytical procedures, process optimization, and quality requirements and their subsequent implications.

Glemser analyzed and understood each facet of this problem quickly, despite the complex situation, conflicting goals, multiple voices from the client, and additional issues arising from the client’s prior “go it alone” efforts. Utilizing their years of experience in content and quality (QMS) and process management systems, Glemser quickly analyzed the client’s existing processes and identified the necessary changes to provide a long-lasting solution that would satisfy the customer’s needs well into the future. Glemser and the client were able to jointly identify and agree upon the true needs of the project—simplicity, accuracy, and efficiency surrounding the vast quantity of content the client creates and the positive implications on the client’s QMS and Process Management.

While this case study includes Process Management and Quality Management issues (including the development of solutions needed to ensure that the client met organizational requirements and regulatory compliance for the FDA and EMA), the main issue Glemser identified pertained to Content Management. This encompassed all forms of the client’s content, including documents, labels, data, and general information. Once this extensive body of information was properly organized into its respective content suites, the client’s problems were quickly resolved.

Case Study

Challenges

The client, a leading worldwide pharmaceutical company based in Germany, was looking for a new, modern, and robust system to manage its test specifications and analytical procedures. As part of the upgrade, the client realized they had an opportunity to evaluate their processes and rethink how they could run more effectively.

The client wanted their new software to meet a number of requirements. It identified those parameters as follows:

Format-independent. The client’s database of testing procedures stores approximately 20,000 test specifications, 80,000 analytical procedures, and a vast array of pharmaceutical information—some of which was in a proprietary database system. The company wanted a state-of-the-art system in which testing specifications could be managed centrally in a non-vendor-specific format.
Reusable documents. In addition to the sheer number of test specifications and analytical procedures, many of these documents were very similar. The client wanted to structure its quality assurance program so they could reuse all pieces and create new testing specifications quickly by assembling pre-approved tests and analytical procedures.
XML. The client preferred XML because it is an independent format that can be read and understood by various tools—and it is not tied to a vendor. In particular, they were looking for an XML editor and XML content. With more than 500 users at the company, they needed XML software that could be easily configured, adaptable to any desired scheme, and had the capability for expansion. Also, it had to be user-friendly and intuitive for those with little-to-no XML working knowledge.
Fewer personnel. The client’s current software was a proprietary system that required specialized support personnel. They wanted their new platform to be based on Documentum—a de-facto standard in the Life Sciences industry for managing sensitive, controlled content and technology used by most pharmaceutical companies. A system built on Documentum could be supported by the existing Document Support teams.
End-of-life technology. The company wanted a system with longevity, specifying a minimum 10-year life span. A system built on Documentum would allow them this longevity.

Solution

The client interviewed approximately 15 vendors and chose Glemser for a number of reasons:
• Glemser understood the company’s problem better than the others.
• Glemser’s approach was based in XML and could generate complex documents on the fly.
• Glemser’s solution was proven on a Documentum platform that the company already had in house.

Glemser’s winning solution included xmContent, a Documentum-based platform that provides a robust set of extensions, allowing companies to meet all applicable compliance requirements through configurable, out-of-the-box functions. xmContent includes the key functionality that many Glemser clients have requested over the course of several hundred production deployments. It is a proven solution that manages more than 10 million documents and is used in a production capacity by more than 15,000 users.

Functions supported by xmContent include:

• 21 CFR Part 11 compliance
• Electronic signatures
• Translation management
• Change management (change requests and change notices)
• Auto-filing and auto-naming
• Lifecycle management
• Specialized security
• Distribution notifications
• Personalized taxonomy-based views of the repository
• Legal hold processing
• Effectivity processing
• To-be-read notifications
• Periodic review

xmContent also provides the necessary functionality to comply with the emerging regulations for XML-based submissions. xmContent allows users to author documents at the fragment level. Even those with little-to-no XML experience can assemble and reuse content fragments across multiple documents. For example, XML-based documents include clinical study protocols and reports, test specifications, and analytical procedures.

Once Glemser was chosen, the company was able to implement and validate the solution in a relatively short period of time (9 months) by using Glemser’s best-practice configurations and implementation accelerators for all System Development Life Cycle (SDLC) deliverables. This included requirements, designs, test scripts, and training material.

Results

Today, Glemser’s solution, built on xmContent and Quark’s XML Author, is one of a handful of strategic corporate systems in quality at this company. The switch has reduced the number of support personnel needed to maintain the system and has allowed the company to stay in compliance with the latest versions of Documentum. It has also given the client the ability to interface with the LIMS systems over web services for increased efficiency.

Because Glemser maintains and supports xmContent, it will continue to be compliant with all Documentum upgrades, providing the longevity the client desired in its new system.