I. Summary
We supported a multinational pharmaceutical company with their migration and transformation of systems as part of the SAP Path to the Cloud initiative through our project quality management services.
Type of provided services: Project Quality Management Services,
Core business platforms: SAP, Non-SAP (Prod, QA, PreProd, DEV) circa 76 to Private Clouds and Microsoft Azure Public Clouds
Project hours: More than 640 project hours
Used methodologies: Risk Assessments, GxP, GISC, Internal Project Methodology
Type of engagement: As a subcontractor of a multinational consulting company
EPPM Services Role in the project: Project Quality Lead
II. Introduction
The multinational pharmaceutical company faced technical and operational challenges with their current systems and made a strategic decision to close their data centres and migrate all divisions and enabling functions' ERP landscapes (including SAP and non-SAP systems) to the cloud by the end of 2022 to meet future-oriented requirements.
In the past, pharmaceutical company had to invest in expensive hardware and infrastructure to maintain and manage their on-premise ERP systems, resulting in slower performance and frequent downtimes. However, with the advancement of cloud technology, all ERP systems are now operated in the cloud, bringing about significant improvements in system stability, performance, and efficiency. The shift to cloud-based ERP systems has made it easier for the company to manage their systems and meet the evolving needs of their customers without costly investments in hardware and infrastructure.
III. Needs/Problems
The client needed to solve the following business problems:
to perform Quality Checks on consulting vendor for transformation deliverables
to track the status of consulting vendor for transformation as well as Pharma Client deliverables
to send notifications and mail reminders to ASO (Accountable System Owner) with regards to status of change tickets and Data Migration Plans / Reports
to provide status overview to Pharma Client program steering committee
IV. Goals/Objectives
The project had following goals and objectives from Quality Assurance:
Pharmaceutical client Quality Spot Checks by the Migration Command Center led by multinational consulting company.
To detect and counteract possible quality deficits during the migration E2E process and the related deliverables.
Define quality criteria's, which were fulfilled within the migration E2E process. A sampling approach was used to verify that these criteria are met.
V. Procedures/Scope of Work
The scope of work and object of the quality assurance were in document reviews and check whether the documents were created, the content were as expected, in case that required the documents were docusigned and stored for audit purposes.
Checked once:
Verified that a project migration plan has been developed and thoroughly reviewed to ensure that it identifies all key stakeholders and their respective responsibilities, along with a clear timeline for migration activities. It was verified that the plan also provided a comprehensive explanation of the migration steps and detailed the measures that would be taken to ensure data security and integrity. It was verified that to optimize the migration process, applications and infrastructure were divided into migration waves and the necessary support was defined. It was verified that during the development of the plan, it was emphasized that other project documents must be consistent with the plan to ensure consistency and accuracy throughout the migration.
It was verified that the Migration Test Strategy document explained how testing was carried out during the migration process, with particular emphasis on performing technical connectivity checks and verifying data.
Checked weekly:
The technical architecture of each system was documented, along with a Technical Risk Assessment to identify potential migration risks and ensure alignment with the Test Strategy, Test Plan, and Test Cases
Prior to migration, an IT Change Request was required to be created and approved in ServiceNow platform for each Configuration Item, with all necessary documents attached.
The Migration Test Plan defined the scope of the test, roles and responsibilities, deliverables, and defect management. The test processes and activities in the Migration Test Plan were based on the Path2Cloud Test Strategy document.
Migration Test Cases Protocol document described the test cases with a focus on infrastructure and interface/connectivity checks, specifying actions to verify corresponding features and functionality. It also included technical connectivity and data integrity checks.
Migration Test Report corresponded to the Migration Test Plan and summarized the test results in accordance with the plan.
Migration Run Book included detailed cutover activities for each application/system migration, forming the basis of change requests and timings and it served as evidence that the migration activities were executed as planned. The Migration Run Book was checked before migration and after migration for completion.
The Migration Qualification activities were summarized and checked to ensure that testing was completed, including any defects or deviations that existed
VI. Timetable
These meetings during the project were necessary for the success of the QA:
MS Teams Weekly on Monday, Wednesday, Friday (Focusing on current P2C topics)
MS Teams Weekly on Tuesday with Cluster Lead Alignment (The purpose of this meeting was to have a frequent alignment between all involved cluster leads to discuss current progress and concerns.)
MS Teams Weekly on Wednesday with P2C Cluster Lead Doc Alignment (The purpose was upcoming migrations (documents) and past / current migration (documents) status)
MS Teams Weekly on Wednesday with QA & Compliance teams – Follow ups (Regular QA meeting discussing current progress and concerns)
MS Teams Weekly on Thursday with Risk & Issue Management (Regular Risk & Issue meeting discussing existing Risks & Issues)
VII. Budget
The quality project budget was part of the global budget and that is part of business information that is not disclosed. From the project point of view, we have delivered more than 640 project hours.
VIII. Key Personnel
As this was a large programme, we will focus here only the key generic roles in which we were participated and interacted.
Business / Process Owners:
The Business Owner was accountable for ensuring that the system and its operation was fit for intended use and in compliance with all applicable regulations throughout the system life cycle. Overall GISC (General Information System Controls) responsibility for a Process Cluster and Releasing the systems.
System Owners:
The Accountable System Owner (ASO) was accountable for the availability, installation, maintenance and support of the system during the complete system life cycle and Maintaining the validated state of the system.
Quality Assurance:
Provided regulatory guidance, independent review and approval over the system life cycle for compliance with relevant IT, GxP and GISC requirements and procedures and Releasing systems.
IX. For Further Information
Visit our website, www.eppm-services.com, or contact Miroslav Czadek, EPPM Services, s.r.o. In case of direct client reference about how we managed project quality or details about our involvement we will share direct contact on request.
Used tools for Project Quality Management:
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