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TEKsystems performed an IT service management (ITSM) assessment to support a pharmaceutical company in achieving greater consistency, efficiency and compliance in their research and development information services division (R&D IS).
Between looking for cost and productivity efficiencies and innovating new products and services that bring business value to the organization, information technology (IT) and information services (IS) departments face another hurdle—regulatory compliance. While industries are governed by different government regulations and standards, in the electronic age no industry is immune.
IT/IS organizations within pharmaceutical companies understand that to be effective and valuable to their organization, they must remain vigilant about compliance. As part of an industry that faces intense scrutiny, pharma organizations need to track and prove that their products have gone through the proper channels and approvals to ensure they comply with government, industry and safety standards. This means tracking who, when and what approvals happen, and ensuring that any changes of authority are dutifully tracked.
Electronic signatures are a significant part of optimizing the compliance process, and also represent the biggest change management exposure risk in pharmaceuticals. Title 21 CFR Part 11 is part of the Code of Federal Regulations that establishes U.S. Food and Drug Administration regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent. However, by implementing IT service management (ITSM) principles and best practices—which align people, processes and infrastructure—IT/IS departments can manage and mitigate the risk that electronic signatures can expose to the organization.
The research and development organization at our client, a pharmaceutical company, oversees the development and testing of four business units that focus on rare diseases, vaccines, animal health and consumer healthcare. All of these entities came through mergers/acquisitions—each bringing their own legacy tools, technologies and processes. Each business unit was using different processes and tools, making collaboration, efficiency and consistency challenging.
Change management was one process that was impacted by differences among the units. As a pharmaceutical company, compliancy is critical to the viability of the company’s core business of developing and getting high-quality products to market. With each unit using different technologies to track electronic signatures/approvals, the client wanted to mitigate change management risks (e.g., consistency, accountability) and ensure they were in compliance with U.S. Food and Drug Administration’s Title 21 CFR Part 11.
The client also wanted to harmonize the use of its ITSM tool, BMC Remedy, within their research and development information services department (R&D IS). Adoption of BMC Remedy varied across R&D IS; some units were not using the tool at all, while others were using it but had room for optimization. This would also support an enterprise-wide initiative to reach a unified support model across the company. In this model, all units would use the same tools and processes, improving support quality and efficiency.
R&D IS needed to understand where each of the units was in relation to adoption of BMC Remedy, and identify the best way to get units to adopt or mature their use of the same tool. They also needed to assess all legacy tools to determine which needed to be retired so there could be more synergies across all the functions. Long-time partner TEKsystems saw an opportunity to help the client improve their processes. We became engaged on this project based on our record of producing solid results and effective relationship-building within the company.
Based upon these goals, the client engaged TEKsystems to perform an assessment of the current ITSM situation across the four R&D functions to identify gaps and prioritize recommendations for process remediation to reach their ultimate goal of harmonization.
TEKsystems would assess the maturity and capability of 10 ITSM processes, procedures and workflows used within R&D IS: Change Management, Configuration Management, Incident Management, Problem Management, Release Management, Asset Management, Service-level Management, Service Catalog Management, Service Request Management and Knowledge Management. To gather this information, we would interview R&D employees and document available data, information and knowledge. This would help us formulate the current state or maturity of ITSM processes and adoption of BMC Remedy.
We would use the current-state findings to compare against ITIL best practices to develop a detailed future-state report. We would perform a gap analysis and identify process maturity gaps and prioritize harmonized process deployment or improvement in order to get R&D IS from the current to future state. Further, we would provide an organizational change management (OCM) plan and provide mechanisms to measure improvements in effectiveness and efficiency in the core ITSM processes.
Our delivery team would consist of a TEKsystems IT Service Management practice architect, delivery manager, solution executive and two technical consultants. The technical consultants would conduct in-person interviews with stakeholders in the tri-state area where the client’s U.S. headquarters are located, as well as meet virtually with stakeholders in France, Germany and Japan.
The client is currently executing on several of our quick-win recommendations. TEKsystems is also in discussions with the client to support additional implementation work.
Our support puts R&D IS in a better position to mature their ITSM capabilities through alignment with their unified support model initiative; create a more collaborative environment that uses commonly defined and documented ITSM terminology, processes and tools; and improve consistency in practice of the core processes to ensure compliance and efficiency in IS operations.
Experienced delivery team.
TEKsystems’ ITSM practice has a team of experts that average 15 or more years of experience in ITSM and ITIL. We also offer complementary services in OCM and Project Management, enabling us to provide a holistic view and roadmap for greater process maturity and adoption.
We established and maintained a good, collaborative working relationship from day one of our partnership. We entered a trusted advisory space—where we did not just deliver a final report, we worked iteratively, sought feedback and made modifications based on the client’s input. In fact, the client specifically asked that the same people come back and work on future engagements.
The client is a global company, so many stakeholders in this engagement were located abroad, making in-person interviews not a time- or cost-efficient option. We interviewed these stakeholders virtually, and were able to adjust our schedule to accommodate the summer vacation period in Europe. This adaptation ensured that all information and input was captured, with minimal impact to the delivery schedule.