Case Study: Delivering a GxP Framework

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A pharmaceutical organization encounters FDA regulations in nearly 50% of the internal initiatives taken on across multiple departments. Due to the highly regulated nature of the pharmaceutical industry, processes and systems required for the development, clinical assessment, manufacturing, testing, and holding of a drug product must be in a state of control and in full compliance with GxP requirements.

These regulations and guidelines are known as GxP (Good Practice); the x is interchangeable for manufacturing, laboratory, clinical, etc. The net result is that any project having a direct or indirect impact on the safety, quality, and efficiency of the drug and/or to the patient populations will require stringent validation. New and existing software or hardware systems and processes, most likely require undergoing qualification and validation.

Validation is the documented process of demonstrating that a system or process meets a defined set of applicable regulatory requirements.

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Challenge: Specialized Project Validation Management

As a result, projects requiring GxP validation often have an expanded set of stakeholders. These projects often require additional internal and third-party services to monitor and control the validation process. Connecting these disparate parties and managing validated projects require certain subject matter expertise, people skills, and an added sense of unbiased responsibility and accountability.  

This was faced by our pharmaceutical drug manufacturing client. Managing their validated projects became too difficult without a dedicated and experienced project manager. This is where the client’s already existing PMO leveraged their relationship with MIGSO-PCUBED to help them.

MIGSO-PCUBED mobilized a team of Pharmaceutical Project Management Consultants with experience dealing with multiple competing stakeholders. Our group of specialist consultants were brought in to manage the large group of validated projects from end to end. 

All process documents are validated under GXP requirements. In addition, any changes to the system (Veeva) managing these documents must be validated as well. In this case, changes to the document submission and overall security modules were made. These changes are under GXP regulation as well.

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Solution: Reconfiguration and Regulatory Compliance

The client used Veeva, an end-to-end document management system, to manage procedural documents in the enterprise. These documents, SOPs (Standard Operating Procedures), controlled the activities involved in creating the final drug product. As a result, these SOPs were under GxP regulation.

MP was tasked with connecting several groups. The first group, the business/operations group, owned the requirements of granting user access in the security module and user permissions in the document submission module. The second group, the vendor, held the expertise to turn the requirements into solutions in the document validation system. The last group, third-party QA, was required to oversee the entire effort and ensure the changes were made according to GxP regulations.

The consultants were responsible for ensuring compliance with regulations and for providing Quality Assurance (QA) and Computer System Validation (CSV) teams who also complied and signed off on deliverables by the book.

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Choosing a Project Management Methodology

Project management methodologies can assist or hinder an effort based on the approach, by being either too rigid or too loose. In this case, there were several unknowns when modifying the permission structure of Veeva, a SaaS (Software as a Service) validation system. As a result, an interactive workshop approach was required. Strict waterfall planning of the features to be implemented would not create the outcomes needed. 

The later stages of the project were prescriptive and known. The project would need to step through a series of phases to ensure the new features were installed as planned and that all stakeholders tested and verified operations. Since the project had iterative components as well as prescriptive components, a hybrid approach was chosen.

A hybrid project requires careful planning because it must utilize the advantages of both predictive and Agile methods. The first phase, definition modifications to the permission structure of the Veeva system, required immediate scheduling for each functional area of the business to be modified in the application. A meeting with the vendor project manager was set. During this meeting, workshops were scheduled over the following weeks with backup sessions added in the event there was a need for additional time.

Completing the Validation

The second phase, validation, was planned with third-party resources and internal QA staff. The third party retained by the organization not only provided resources to oversee and certify the regulated QA process, but also brought a sophisticated methodology for managing the IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) FDA protocols through the QA and production environments.

These alignment meetings are often more complex than the workshop scheduling with third-party software specialists. Multiple sessions are required to ensure the proper aspects of the protocols are applied.

The result is a two-phased project that is well-planned and ready for execution. The first phase covers the configuration, the second covers required regulatory compliance. Keeping both phases on track becomes key to establishing consistent performance in scheduling and budgeting for the organization.

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Benefits: Validated Project Success

MP successfully combined the right people with the right skillsets to complete a customized hybrid approach to execute the validation project. As a result, MP played a pivotal role in maintaining good vendor management practices.

After MP’s arrival, the client recognized that the overall validation time was shortened dramatically, resulting in cost savings both for vendor contracts and for internal labor. The consultant team is now looking to implement a more quantitative reporting structure that includes KPIs to better measure the project’s success going forward.

By aligning project management principles with the existing status and reporting tools the organization had available, consistent communication was achieved. The validation software was successfully implemented, and the set of projects were organized all in the rime allotted to maintain regulatory requirements.

Through enhanced communication, immediate escalation of issues, and providing focus to the team, the team was able to maximize efficiency through the management of user permissions in Veeva. MP’s standardized and well-documented approach was very well received by the client. In fact, they asked to use this approach as a standard for all project managers in moving forward.

Thank you very much for keeping the team on course. It was a rocky project but perfectly managed!

The successful validation project continues to enable the client’s success for the future, and MP is excited to continue supporting them throughout this journey.

This article was written by Don Farr and Sirisha Pudipeddi.