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.