Originally posted on the ION Pharma website here.
The goal: To empower myGCP, a regulatory intelligence learning solution by GCP Central, to navigate through evolving industry demands. How? By enhancing its platform to integrate new collaboration requirements from the Netherlands Federation of University Medical Centres (NFU) and internal specifications from GCP Central. These adjustments required thorough verification in a compliant manner to ascertain the seamless incorporation and proper functioning of all mandated requirements within the platform.
Highlights:
- The project was completed on schedule and within the allocated budget.
- Validation activities and deliverables were successfully executed and delivered.
- Optimum Quality B.V.’s MR4DevOps validation tooling has been implemented successfully to maintain the validated status and manage any future changes.
Background
Our client provides a regulatory intelligence learning solution myGCP for clinical researchers in biotech, pharma, CRO’s and hospitals. It consists of accredited Good Clinical Practices (GCP), Clinical Trials Regulation (EU CTR), Medical Device Regulation (MDR), Arzneimittelgesetz (AMG) and Medical Researching involving Human Subjects Act (WMO) e-learning modules, an online community, tools, news updates, cases and exams.
The myGCP system provides continuous and up to date GCP, EU CRT, MDR, AMG, and WMO training to staff of life-science companies and direct customers (individual users) through an online learning platform by delivering and providing online training, training records and training certificates to clinical and non-clinical staff working in GxP regulated industries and healthcare.
The myGCP application is a combination of a Learning Management System (LMS) and a Content Management System (CMS) allowing the creation of eLearning modules and Licenses to be provided to Customers and End Users. A License can consist of various Module types, including eLearning modules, Exam modules, Real Life Meeting modules, PowerApp modules and Select modules.
By using the learning application learners learn about the essential rules and regulations applicable to their role in an active, fun and practice-based way by providing continuous access to compliance knowledge and explain how clinical research is set up and conducted according to the regulations, such as Good Clinical Practice, the EU Regulation and Privacy laws.
Objectives
GCP Central has recently established a new collaboration with NFU, thereby introducing additional requirements to be adhered to on the myGCP application. Additionally, GCP Central has undertaken modifications in the recent period and has the desire to include new internal specifications related to the application’s functionality. These adjustments necessitate thorough verification in a compliant manner to ascertain the seamless incorporation and proper functioning of all mandated requirements within the platform.
The objective of this case was to define the strategy, activities, deliverables and responsibilities for validation of the myGCP system and to ensure that the effort is consistent with applicable regulatory requirements procedures, and business requirements.
The goal was to incorporate advanced functionalities that would better support their project workflows and meet the specific requirements of their end clients. The enhancements focused on four key areas:
- Dependencies Management: Introduce a system for defining and managing learning module dependencies, allowing content managers to set predecessor and successor relationships between learning modules.
- Meeting Scheduling: Integrate a robust meeting scheduling feature that allows for seamless registration, attendance and coordination of on-site classroom meetings, including integrated calendar functionality to schedule meetings directly within myGCP.
- Advanced Modules: Develop and implement advanced modules that provide deeper insights and specialized functionalities tailored to the needs of specific projects or industries. Ensuring modules could be customized and configured based on the specific needs of each client project.
- Continuous Learning Tracking: Implement a system that regularly assesses users to ensure ongoing knowledge and skill development. Through quizzes or tasks, it tracks performance and can extend certifications based on consistent results. The process is customizable, allowing adjustments in goals, assessment frequency, and required scores.
Approach
The project approach was designed to ensure that all enhancements and modifications to the myGCP application were implemented in a compliant, systematic, and controlled manner. This approach consisted of several key steps:
1. Requirement Gathering and Analysis
The project began with a thorough analysis of the new requirements introduced by the collaboration with NFU, as well as the internal specifications identified by GCP Central. This phase involved close collaboration with stakeholders to ensure a thorough understanding of both regulatory and business needs.
2. Design and Development of Verification Strategy
A detailed verification strategy was developed, focusing on compliance with applicable regulatory standards, such as GxP guidelines. This strategy included the creation of a validation plan that outlined the necessary steps, validation activities, and documentation requirements, to ensure that all new functionalities and modifications met the required standards.
3. Implementation of Validation Tooling
The project utilized Optimum Quality B.V.’s MR4DevOps as the primary validation tool. This involved setting up an environment to manage the verification process, including the formulation and documentation of accurate requirements, creation of traceability matrices, and the development of test cases. The validation tool was configured to handle version control, traceability, and test execution, ensuring that all changes were tracked and validated effectively.
4. Execution of Test Cases and Validation
Once the verification strategy and validation tooling were in place, the project team executed a series of rigorous test cases to validate the new features and modifications. This phase ensured that all dependencies, meeting scheduling functionalities, and advanced modules were functioning as intended and in compliance with regulatory standards. The testing process also included user acceptance testing (UAT) to verify that the system met the end users’ needs.
5. Documentation and Compliance Assurance
Throughout the project, detailed documentation was maintained to ensure full traceability and accountability. This included the creation of validation reports, test execution logs, and compliance documentation that aligned with regulatory requirements. These documents served as evidence of compliance and were crucial for maintaining the system’s validated status.
6. Controlled Deployment and Monitoring
The new functionalities were deployed in a controlled manner, with careful monitoring to ensure that the integration was seamless, and that the system operated as expected post-deployment. Any issues identified during this phase were promptly addressed, and corrective actions were taken to ensure ongoing compliance.
7. Knowledge Transfer and Handover
Upon successful completion of the project, the validation tool, along with all related content and maintenance procedures, was fully transferred back to GCP Central. This ensured that the client had the necessary knowledge to manage future changes and maintain the system’s validated status independently.
By instituting this comprehensive and compliant verification process, the project not only achieved its objectives but also established a robust framework for future enhancements, ensuring the long-term reliability and compliance of the myGCP application.
Solution
ION Pharma played a crucial role in this project, providing both advisory and hands-on delivery services to ensure the successful implementation and validation of the myGCP application. The contributions were multifaceted and essential to the project’s overall success:
Advisory Role in Requirement Formulation
ION Pharma worked closely with GCP Central to define and refine the project’s requirements, ensuring they were both complete and aligned with regulatory standards. This involved in-depth consultations with key stakeholders to capture all necessary functional and non-functional requirements, including those introduced by the new collaboration with NFU. ION Pharma’s expertise in regulatory compliance and system validation was instrumental in ensuring that the requirements were clearly defined, accurately documented, and met all relevant guidelines.
Development of Test Cases
ION Pharma took a lead role in the creation of detailed test cases within the validation tooling. These test cases were methodically designed to cover all aspects of the myGCP system’s functionality, including new features like dependencies management, meeting scheduling, and advanced module integration. The test cases ensured that each requirement was fully tested for compliance, functionality, and performance, providing a robust framework for validating the system’s enhancements.
Implementation of Validation Tooling
ION Pharma was responsible for setting up and configuring the Optimum Quality B.V.’s MR4DevOps validation tool, which served as the central platform for managing the project’s verification activities. This involved tailoring the ADO environment to support traceability, version control, and test execution, ensuring that all validation activities were documented and tracked efficiently. The tool was configured to meet the specific needs of the project, enabling seamless management of the entire validation process.
Ongoing Support and Maintenance
Throughout the project, ION Pharma provided continuous support, guiding the GCP Central team through the validation process. This included offering expertise on best practices for system validation, ensuring that all activities adhered to the highest standards of compliance. ION Pharma also assisted in troubleshooting any issues that arose during the testing and validation phases, ensuring that the project stayed on track and met its deadlines.
Knowledge Transfer and Handover
Upon completion of the project, ION Pharma ensured a smooth transition of the validation tool and all related content back to GCP Central. This included a handover of the validation tool, along with detailed documentation on its configuration, usage, and maintenance. This handover ensured that GCP Central could maintain the validated status of the myGCP system and efficiently manage any future changes.
Through its advisory and delivery roles, ION Pharma not only ensured the accurate formulation and registration of requirements and test cases but also established a sustainable validation process that GCP Central could rely on for future projects. This solution was key to achieving the project’s objectives and maintaining the ongoing compliance and functionality of the myGCP system.
Results
The project objectives were successfully met, adhering to the set timelines and budget constraints. The enhancements implemented in the myGCP system had a significant and positive impact on its functionality and alignment with industry requirements:
Achievements and Timeline
The project was completed on schedule and within the allocated budget, demonstrating effective project management and execution. This achievement was a result of detailed planning, diligent oversight, and the collaborative efforts of all stakeholders involved.
Key Enhancements
- Dependencies Management: The introduction of a system for managing learning module dependencies allows content managers to define and manage relationships between modules. This enhancement streamlines the learning process by ensuring that prerequisites and follow-up modules were logically sequenced, thereby improving the coherence and effectiveness of the training content.
- Meeting Scheduling: The integration of a robust meeting scheduling feature facilitates seamless registration, coordination, and management of on-site classroom meetings. The built-in calendar functionality allowed for efficient scheduling and tracking of meetings, ensures that training sessions are well-organized and accessible to participants.
- Advanced Module Integration: The development and implementation of advanced modules provide deeper insights and specialized functionalities tailored to specific project needs. This customization capability allows for more targeted and relevant training, aligning the system with the unique requirements of different clients and industries.
- Continuous Learning Tracking (Powerapp): The continuous learning tracking facilitates recertification through continuous learning, using a Powerapp module integrated via LTI and API. This app delivers quizzes to users, with an 80% score required to extend certification. The CMS allows customization of settings, including initial score, monthly learning goals, and required score for recertification.
- System Strengthening: The enhancements significantly strengthen the myGCP system by improving its alignment with industry standards and client specifications. The system’s capability to handle complex project requirements and deliver high-quality, compliant training solutions was markedly enhanced.
Implementation of Validation Tooling
The successful implementation of the Optimum Quality B.V.’s MR4DevOps validation tooling was a key factor in the project’s success. This tool facilitates:
- Efficient Management of Changes: The validation tooling provides a structured approach to manage changes to requirements and validation processes. This ensures that any modifications are systematically documented, reviewed, and implemented, reducing the risk of errors and ensuring ongoing compliance.
- Traceability: The tool offers robust traceability features, allowing for clear tracking of requirements, changes, and validation activities. This traceability is crucial for maintaining compliance and providing evidence of adherence to regulatory standards.
- Test Script Versioning and Execution: The validation tool enables effective versioning and execution of test scripts. This capability ensures that all tests are executed as planned and that any issues were promptly identified and addressed. The version control also facilitated the maintenance of test cases over time, accommodating future updates and modifications.
Overall, the project’s successful execution not only met but exceeded expectations, delivering a more robust and compliant myGCP system. The improvements and tools implemented during the project have positioned the system to better meet the evolving needs of its users and the stringent demands of the regulatory environment.
Learn more
Want to know more about implementing future-proof validation tooling based on Optimum Quality B.V.’s MR4DevOps to efficiently manage any future changes? Get in contact with them.
You can also read more on ION Pharma’s program management and project delivery approach, or about their validation activities and services.
