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.