Case Study: 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 ef ciencies 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 Technologies (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 ef ciently. 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 con guration 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.

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