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.


Company Harmonizes Global Business Requirements Into a Single Quality Management System

Companies today continue to move away from using multiple, local quality management processes in favor of a single, common process that can be implemented across the entire company. Going global, as it’s called, allows companies to better align global process requirements, provide continuity, and increase overall efficiency and accuracy. The bottom line: it consolidates IT infrastructure and maintenance, thereby reducing costs.

Making the move to global, however, can challenge corporations in many ways.

Challenge

A multinational pharmaceutical corporation headquartered in New York City began consolidating its quality management system approximately a decade ago with the help of Glemser Technologies.

From a business standpoint, doing so meant the company had to harmonize its local processes and give up on-site efficiencies that did not align with the new global approach. From a technical standpoint, they had to meet challenges both in terms of system design and increased system load.

This company uses Sparta Systems TrackWise software as its enterprise quality management solution (EQMS). Over the course of approximately 5 years, the company successfully moved its change management group’s existing, site-based TrackWise system to one global quality system instance.

Then the challenge really began: due to the success of the transition, the scope of this global instance incrementally expanded in the intervening years to include the quality management processes of other business groups, such as audit management, complaint investigations and commitment tracking.
As the company consolidated its quality management system, it found itself needing to support global process change while also supporting system growth.

Solution

The pharma company turned to Glemser (already a partner on Custom Documentum solutions) to help manage the challenges that cropped up during these transitions. Today, the company continues to rely on Glemser to manage problems presented by system growth.

Initially, Glemser provided an analyst to the change management group to identify each site’s requirements and ensure the global process approach was met. Based on this review, the analyst suggested system implementation approaches that allowed some local site differences to remain in place while maintaining alignment with global process requirements.

Using the analyst’s recommendations to guide them, Glemser’s implementation team then consolidated the different quality management systems into one. They also implemented techniques such as load balancing and distribution to manage the increased demand on the system.

As the scope of the system increased to include the quality management of other business groups, Glemser’s team instituted a set of implementation rules. These rules manage growth by maintaining continuity between common data elements, such as product data, so that the pharma company can attain its global metric requirements more efficiently. All new groups must adhere to these rules when transitioning to the global instance.

Over time, as multiple work streams and more complex business processes moved into the global instance, Glemser expanded its implementation team. Due to its wide range of services, Glemser was able to provide this company with a holistic team that could handle all aspects of the implementation. In addition to the analyst and configuration and validation consultants already on the team, Glemser added additional skill areas such as web services and reporting expertise.

The team maintains detailed knowledge of the quality management system. It also has the ability to understand, adhere to and enforce the implementation rules. Overall, the team provides continuity in implementation techniques and day-to-day working relationships with the company’s technology and business teams.

Results

Glemser’s global system implementation has ensured the company’s local sites are now aligned with global business process requirements. The success of the initial implementation convinced other business process groups within the company to move into the same global quality system instance, rather than build their own individual systems.

Today, the scope of the system continues to expand. Glemser’s ability to continuously grow and provide implementation resources for a wide range of technologies allows the onsite team to act as a gatekeeper for this company. The team retains institutional knowledge about the system, and practices consistent implementation techniques throughout the life of the system.


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.


Quality Implementations for Life Science Client under a Consent Decree

The Client

The client is a diversified, multinational, life sciences company. The consumer division of this company manufactures and sells health care products worldwide.

The Situation

In one of the company’s divisions, the US Food and Drug Administration (FDA) found several violations during routine inspections. These included a variety of problems such as the performance of operations outside of approved standard operating procedures, outdated procedures, mislabels and more. As a result, the FDA issued warning letters.

Unfortunately, the company could not consistently demonstrate sufficient control of its quality systems to the FDA in compliance with current good manufacturing practices. After the company recalled several products, and received inspectional observation reports, called 483s, and a warning letter from the FDA, the FDA placed this company under a consent decree.

A consent decree is a legal agreement between a company and the FDA under which the company agrees to address specific violations and implement oversight processes. Consent decrees include heavy fines, reimbursement to the government for applicable inspection oversight costs, commitments to due dates for specific actions and penalties for non-compliance. Entering a consent decree can have a major impact on the affected manufacturing sites, and obtaining a release from a consent decree typically takes many years. As a result, a consent decree could cost a life sciences company millions of dollars in regulatory fines, additional expenses, and lost revenue.

The Solution

While implementing quality system changes may seem straightforward on the surface, changing a corporate culture along with its legacy quality management systems is a large and complex task, involving people, processes and technologies. The client chose to secure release from the consent decree by embarking on an eight-year program.

During the first three years under its consent decree, the company:

  • Remediated known issues
  • Improved its quality systems
  • Defined new quality processes
  • Implemented external oversight
  • Ensured internal governance oversight
  • Implemented quality reporting metrics

Over the remaining five years, the company will:

  • Sustain new quality processes
  • Continue external oversight
  • Monitor and measure performance
  • Implement additional quality system improvements
  • Participate in routine regulatory audits

The company started consent decree remediation by defining the quality standards for applicable business functions, implementing interim controls and organizing the overall quality system into distinct quality system elements, such as quality assurance, documentation control, new product development, technology transfer, manufacturing operations, etc. Each quality system element was broken down into multiple process steps, each of which was addressed in the following approach:

  1. Process – The implementation of new procedures to address critical business functions.
  2. Remediation – The execution of specific activities to address known product- and process-related gaps. Remediation steps included updating legacy documents, such as finished product specifications, to comply with new procedures provided by related process steps.
  3. Information Technology (IT) – The updates to legacy IT systems to address known issues and the implementation of new IT systems to ensure compliance with new procedures.

Although the approach to executing process, remediation and IT can vary significantly, each of these steps were remediated through the following four phases.

  1. Plan and Design

The intent of the plan and design phase is to define the process for effective and compliant quality procedures. During this phase, teams organized by quality system elements:

  • Reviewed applicable quality standards and known gaps and issues
  • Assessed “as is” processes and developed “to be” processes with detailed process maps
  • Developed a detailed project plan and metrics for measuring compliance
  • Signed a deliverables concurrence document to align participant expectations with respect to deliverables
  1. Implementation

The intent of the implementation phase is to make the quality system effective by training employees to run quality operations according to approved procedures supported with validated quality IT systems. During this phase, teams organized by quality system elements:

  • Developed and approved new standard operating procedures
  • Implemented and updated IT systems required to support new procedures
  • Implemented metrics reporting
  • Trained users on the new processes
  • Developed trace matrices to ensure that all quality standard elements and gaps were addressed
  • Conducted an independent assessment to confirm that new processes were adequate and in place
  1. In Use

The intent of the “in use” phase is to have employees run the business according to the new quality procedures while assembling compliance documentation in an evidence binder for inspection by the FDA. During this phase, teams organized by quality system elements:

  • Conducted routine business using newly effective procedures
  • Gathered “in use” evidence to support subsequent verification
  • Captured and reported applicable metrics
  • Received “hypercare” support for six months by core team members to feel comfortable with the new quality standards and procedures
  1. Verification

The intent of the verification phase is to have internal and third-party auditors review the evidence binders and resolve and remediate any findings through the non-conformance quality process. During this phase, auditors organized by quality system elements:

  • Assessed evidence to ensure that “in use” business activities were compliant with applicable quality procedures
  • Appraised points for future evaluation to ensure that deferred “in place” confirmation observations were addressed and closed

 

Results to Date

The company has met all of its commitments to the FDA so far. The development of the company’s quality system elements and procedures have followed the process described above and have been confirmed and verified when required. Since this is the first time that the company entered a consent decree, this process had to be modified along the way to address issues and implement improvements based on lessons learned and evolving best practices. 

 

Future Outlook

The company is on track to re-establish its quality system with strong standards and processes within the first three years of its consent decree. The company has demonstrated its ability to successfully execute every aspect of its consent decree work plan. The next milestone is to obtain certification for each affected site to manufacture quality products for US consumers. After certification, the FDA will perform two audits in the fourth year and then one annual audit in the subsequent three years. The company will demonstrate the sustainability of its quality system by successfully completing FDA audits over a five-year period, with the goal of emerging from its consent decree over a total of eight years.

 

Glemser’s Involvement

Glemser consultants combined deep domain knowledge, a practical understanding of regulatory requirements and a proven track record of successfully implementing enterprise compliance software to help the client with several critical quality system element work streams.

Specifically, Glemser consultants:

  • Performed project management activities including:
    • Program management of project consultants
    • Project planning and coordination of activities and deliverables
    • Definition of risks and management of mitigation strategies
    • Facilitation of project meetings
    • Submission of status reports
    • Issue escalation and management of resolution
  • Gathered and assessed IT requirements in support of new processes
  • Performed process analysis and modeling
  • Maintained budgets and resource requirements
  • Facilitated various process excellence activities
  • Coordinated and managed training activities
  • Managed interdependencies between different quality system elements
  • Facilitated workshops to analyze processes and develop process maps

Glemser helped the client meet critical project needs by providing consultants that have deep life sciences domain experience, knowledge of regulations, expertise in applying information technology, an ability to drive client behaviors, and the strong desire to make clients successful.


Quality Management Case Study (Quality Modules)

Executive Summary

In this case study, Glemser Technologies worked with an international client to align the quality management of multiple regions. Through the process, Glemser simplified the client’s quality management systems to enable easier compliance with FDA regulations. Handling a complicated schedule (the World Cup was a minor scheduling conflict), client politics, and four languages across three regions, Glemser was able to meet the client’s goal with a cloud-based solution that unified the analytical insights and reporting.

Case Study

Challenges

Three of the client’s North and South American regions were being spun off as a separate company. The scope of the problem included various types of information in the English- and French-speaking North American, Spanish-speaking South American, and Portuguese-speaking South American regions. Further, quality system applications were not implemented consistently across these regions. For example, change control was configured one way in Columbia and a different way in Brazil. The three regions generated volumes of historical quality data with narrative texts in English, French, Spanish, and Portuguese. The client wanted to bring seven different systems into five applications on one system or platform to simplify compliance with FDA regulations for Good Manufacturing Practice (GMP) and electronic signatures and records (FDA Part 11).

In both South American regions, there was tension between the regional head offices and their respective local sites. The head offices wanted to implement quality management according to industry best practices, and their respective local sites wished to bring all old quality data forward into the new system.

Solution

To harmonize the approaches, Glemser conducted workshops, tactically scheduled around World Cup soccer tournaments, with in-person and remote participants. Ultimately, the client wanted a new, fresh, and proven quality management system to contain all its current quality content. Rationalizing the data proved to be the complicated part of the project. The client needed someone who knew the industry requirements and could deploy a customized solution, instead of one simply out of the box. Glemser developed a hybrid solution of a traditional approach combined with best practices for change control.

The following quality system applications were implemented:
• Management of Change, which controlled product changes across lines of business
• Document Control, which managed quality documents, attached forms, and formulas
• Permits, which demonstrated compliance with air quality standards in dozens of locations
• Corrective Actions, which resolved issues that affected quality system elements
• Audit Management, which initially focused on certifying critical external suppliers

Results

These applications were configured on top of a cloud-based quality management platform that provides a consistent user experience. A single repository supports analytical insights and reporting across all quality applications. These applications typically take 4-to-6 weeks to configure and validate. In this implementation, the client’s modules took 6 months: approximately 3 months to configure, import complex data into, and validate the five applications, and 3 months to roll them out in stages across the three regions.


Process Management Case Study (Changing Medical Device Labels)

Executive Summary

In this case study, Glemser Technologies worked with a client to smooth the integration of a new acquisition. The client purchased a competitor in order to create a more well-rounded medical device group. Once purchased, the new group had to be integrated through a potentially complicated, laborious process of rebranding and relabeling the products to comply with the new parent companies’ requirements and new European Union requirements. Glemser worked with the client to create a new, smoother process to be deployed in the coming years.

Case Study

Challenges

A life sciences client purchased a competitor’s surgical vision organization to combine with its own consumer vision group in order to broaden its range of optical solutions and create synergy in an integrated vision medical device group. A complicated process for changing labels evolved from a series of observations in quality audits that resulted in Corrective and Preventive Actions (CAPAs) in the acquired company. Programs to rebrand medical device labels and ensure compliance with the emerging European Medical Device Regulation (EU MDR) highlighted the need for a streamlining of the cumbersome quality process to change product labels.

Solutions

Glemser analyzed the labeling change procedure and developed the following recommendations to improve the process:

• A comparative labeling change benchmark with a similar medical device group
• An optimized set of process steps built through workshops with the labeling team
• An intake form to improve initial planning of labeling changes
• A workflow diagram to establish an accurate initial scope of a labeling change
• Proposed regulatory guidance documentation, including examples, for the labeling change team to correctly interpret North American and European labeling requirements

Results

Glemser presented its recommendations to Supply Chain, Regulatory, and Quality leaders in a program that included approaches to challenges in process, organization, information, and technology. This allowed the labeling team to take steps to improve the change process. Glemser also collaborated with leaders in Supply Chain and Finance to develop a rough-cut business case to seek funding for full deployment of labeling change optimization over the next couple of years.


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.