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.