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 efficiencies 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 (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 efficiently. 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 configuration 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.


Quality Implementations for Life Science Client under a Consent Decree

The Client

The client is a diversified, multinational, life sciences company. The consumer division of this company manufactures and sells health care products worldwide.

The Situation

In one of the company’s divisions, the US Food and Drug Administration (FDA) found several violations during routine inspections. These included a variety of problems such as the performance of operations outside of approved standard operating procedures, outdated procedures, mislabels and more. As a result, the FDA issued warning letters.

Unfortunately, the company could not consistently demonstrate sufficient control of its quality systems to the FDA in compliance with current good manufacturing practices. After the company recalled several products, and received inspectional observation reports, called 483s, and a warning letter from the FDA, the FDA placed this company under a consent decree.

A consent decree is a legal agreement between a company and the FDA under which the company agrees to address specific violations and implement oversight processes. Consent decrees include heavy fines, reimbursement to the government for applicable inspection oversight costs, commitments to due dates for specific actions and penalties for non-compliance. Entering a consent decree can have a major impact on the affected manufacturing sites, and obtaining a release from a consent decree typically takes many years. As a result, a consent decree could cost a life sciences company millions of dollars in regulatory fines, additional expenses, and lost revenue.

The Solution

While implementing quality system changes may seem straightforward on the surface, changing a corporate culture along with its legacy quality management systems is a large and complex task, involving people, processes and technologies. The client chose to secure release from the consent decree by embarking on an eight-year program.

During the first three years under its consent decree, the company:

  • Remediated known issues
  • Improved its quality systems
  • Defined new quality processes
  • Implemented external oversight
  • Ensured internal governance oversight
  • Implemented quality reporting metrics

Over the remaining five years, the company will:

  • Sustain new quality processes
  • Continue external oversight
  • Monitor and measure performance
  • Implement additional quality system improvements
  • Participate in routine regulatory audits

The company started consent decree remediation by defining the quality standards for applicable business functions, implementing interim controls and organizing the overall quality system into distinct quality system elements, such as quality assurance, documentation control, new product development, technology transfer, manufacturing operations, etc. Each quality system element was broken down into multiple process steps, each of which was addressed in the following approach:

  1. Process – The implementation of new procedures to address critical business functions.
  2. Remediation – The execution of specific activities to address known product- and process-related gaps. Remediation steps included updating legacy documents, such as finished product specifications, to comply with new procedures provided by related process steps.
  3. Information Technology (IT) – The updates to legacy IT systems to address known issues and the implementation of new IT systems to ensure compliance with new procedures.

Although the approach to executing process, remediation and IT can vary significantly, each of these steps were remediated through the following four phases.

  1. Plan and Design

The intent of the plan and design phase is to define the process for effective and compliant quality procedures. During this phase, teams organized by quality system elements:

  • Reviewed applicable quality standards and known gaps and issues
  • Assessed “as is” processes and developed “to be” processes with detailed process maps
  • Developed a detailed project plan and metrics for measuring compliance
  • Signed a deliverables concurrence document to align participant expectations with respect to deliverables
  1. Implementation

The intent of the implementation phase is to make the quality system effective by training employees to run quality operations according to approved procedures supported with validated quality IT systems. During this phase, teams organized by quality system elements:

  • Developed and approved new standard operating procedures
  • Implemented and updated IT systems required to support new procedures
  • Implemented metrics reporting
  • Trained users on the new processes
  • Developed trace matrices to ensure that all quality standard elements and gaps were addressed
  • Conducted an independent assessment to confirm that new processes were adequate and in place
  1. In Use

The intent of the “in use” phase is to have employees run the business according to the new quality procedures while assembling compliance documentation in an evidence binder for inspection by the FDA. During this phase, teams organized by quality system elements:

  • Conducted routine business using newly effective procedures
  • Gathered “in use” evidence to support subsequent verification
  • Captured and reported applicable metrics
  • Received “hypercare” support for six months by core team members to feel comfortable with the new quality standards and procedures
  1. Verification

The intent of the verification phase is to have internal and third-party auditors review the evidence binders and resolve and remediate any findings through the non-conformance quality process. During this phase, auditors organized by quality system elements:

  • Assessed evidence to ensure that “in use” business activities were compliant with applicable quality procedures
  • Appraised points for future evaluation to ensure that deferred “in place” confirmation observations were addressed and closed

 

Results to Date

The company has met all of its commitments to the FDA so far. The development of the company’s quality system elements and procedures have followed the process described above and have been confirmed and verified when required. Since this is the first time that the company entered a consent decree, this process had to be modified along the way to address issues and implement improvements based on lessons learned and evolving best practices. 

 

Future Outlook

The company is on track to re-establish its quality system with strong standards and processes within the first three years of its consent decree. The company has demonstrated its ability to successfully execute every aspect of its consent decree work plan. The next milestone is to obtain certification for each affected site to manufacture quality products for US consumers. After certification, the FDA will perform two audits in the fourth year and then one annual audit in the subsequent three years. The company will demonstrate the sustainability of its quality system by successfully completing FDA audits over a five-year period, with the goal of emerging from its consent decree over a total of eight years.

 

Glemser’s Involvement

Glemser consultants combined deep domain knowledge, a practical understanding of regulatory requirements and a proven track record of successfully implementing enterprise compliance software to help the client with several critical quality system element work streams.

Specifically, Glemser consultants:

  • Performed project management activities including:
    • Program management of project consultants
    • Project planning and coordination of activities and deliverables
    • Definition of risks and management of mitigation strategies
    • Facilitation of project meetings
    • Submission of status reports
    • Issue escalation and management of resolution
  • Gathered and assessed IT requirements in support of new processes
  • Performed process analysis and modeling
  • Maintained budgets and resource requirements
  • Facilitated various process excellence activities
  • Coordinated and managed training activities
  • Managed interdependencies between different quality system elements
  • Facilitated workshops to analyze processes and develop process maps

Glemser helped the client meet critical project needs by providing consultants that have deep life sciences domain experience, knowledge of regulations, expertise in applying information technology, an ability to drive client behaviors, and the strong desire to make clients successful.


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.