Case Study: Glemser’s robust quality management solution implemented at Boehringer Ingelheim becomes key strategic component for improved test specifications and analytical procedures

Boehringer Ingelheim is a family-owned global corporation which was founded in 1885 in Ingelheim, Germany. It employs more than 47,700 people on all continents and generated net sales of EUR 13,317 million in 2014. The company was looking for a new, modern and robust system to manage its test specifications and analytical procedures. Boehringer Ingelheim seized the opportunity to evaluate its processes and rethink how it could improve its testing specifications and analytical procedures.


Challenges

Boehringer Ingelheim wanted its new software to meet a number of requirements. It identified those parameters as follows:

  • Format independent. Boehringer Ingelheim created 20,000 in a non-vendor specific format.
  • Reusable documents. Test specifications and analytical procedures share similar informations. Boehringer Ingelheim wants the flexibility to reuse parts and pieces of existing documents to allow for quick creation by assembling preapproved tests and analytical procedures.
  • XML. Boehringer Ingelheim liked 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 XML editor and XML content. With 500 users at the company editing documents 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.
  • End-of-life technology. Boehringer Ingelheim wanted a system with longevity, specifying a minimum 10-year life span. Once again, they looked for a system built on Documentum to give them that longevity.

Solution

Boehringer Ingelheim 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, and the 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, used in a production capacity by more than 15,000 users, and to manage more than 10 million documents.

For example, xmContent supports, among other functions:

  • 21CFR11-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 important functionality needed to comply with the emerging regulations for XML-based submissions. xmContent allows users to author documents at the fragment level, and content fragments can be assembled and re-used across multiple documents (with little to no XML knowledge). 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 (9-month) period of time, 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 the strategic corporate systems in quality at Boehringer Ingelheim. The switch has reduced the number of support people needed to maintain the system, and has allowed the company to stay in compliance with the latest versions of Documentum. It has also given Boehringer Ingelheim the ability to interface with the LIMS systems over web services for increased efficiency.

Because xmContent is maintained and supported by Glemser, it will continue to be compliant with all Documentum upgrades, providing the longevity Boehringer Ingelheim desired in its new system.