Success in four steps
The project involved four major steps:
- A — Assess/C — Compare: Analysis of the IT-QMS and comparison with the most current regulatory requirements and best practices. These include regulations relevant for an IT-QMS, such as EU GMP Annex 11 and FDA 21 CFR Part 11. Based on years of experience, our project employees have incorporated not only best practice models such GAMP 5 and IT Infrastructure Library (ITIL), but also the experience gained by ARCONDIS consultants in the course of over 550 compliance projects.
- I — Identify: Identification of gaps and the creation of a plan for minimizing risks and optimizing the IT-QMS based on specific requirements of the international company with expansion plans. The main elements of the measure plan included the introduction of a central CSV inventory, a reduction in the number of standard operating procedures (SOPs) and the introduction of concrete instructions, checklists and reusable templates to simplify processes and reduce workloads.
- N — Neutralize: Timely completion and implementation of all actions. In this phase, all specifications, instructions and templates were developed and approved, and Acino staff were trained accordingly. An emphasis was placed on adapting the documents to customer-specific requirements, roles and to the Acino environment.
- O — Optimize: Optimization of processes and tools without interrupting everyday business. The framework was optimally tailored to Acino based on initial experiences gained in practice. In addition, the foundation for continuous improvement was established in this phase in order to ensure that optimization of the IT-QMS doesn’t come to an abrupt halt once the project ends, but rather that the framework is continually optimized in the future and is adapted to changing conditions.
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And that’s what Acino says…
“What I especially appreciate about ARCONDIS is that we weren’t left alone with a concept – they accompanied us through our everyday operations. Their comprehensive expertise combined with practical implementation was extremely convincing. With the new IT-QMS, we’ve won on two fronts: We are not only compliant, but are also more efficient and customer-oriented in IT thanks to the best practices of ARCONDIS.”
— Giuseppe Pileggi, CIO Acino
Based on the gap analysis, ARCONDIS developed a concept optimizing the IT-QMS following best practices, rebuilding it and preparing it for the company’s future plans. In optimizing the IT-QMS, the first step focused on establishing overarching structures consisting of three pillars:
- The superordinate QM directive serves as the primary guideline, defining a common understanding and strategy for the Acino IT quality management system.
- In addition, a lifecycle SOP was developed that covered the entire lifecycle of applications, services and IT infrastructure components, from procurement, commissioning, change requests and updates through to decommissioning. The framework is based on ITIL and CSV standards to meet not only requirements placed on GxP-relevant applications, but also to define processes following best practices in IT service management.
- Another component of the new IT-QMS is a risk-based assessment process. The result is clarity regarding which applications and services fall under GxP guidelines. At the same time, the newly created inventory serves to track all relevant information, in particular GxP relevance, the validation or qualification status and the respective system owner.
After the structure was established, the individual SOPs were optimized according to the result of the gap analysis, and were updated, consolidated or removed completely. Considering the aspect of lean compliance, the number of processes was cut nearly in half and defined in more concrete terms. Thanks to close collaboration with the customer, Acino-specific requirements were integrated into the processes and all documents accepted promptly. Each SOP contains concrete instructions and examples. Together with the templates, forms and checklists created based on best practices, this catapults the employees at Acino to a whole new level of efficiency and understanding with regard to IT quality processes.
In the last but not least step, ARCONDIS accompanied the QM team at Acino in introducing and rolling out the optimized framework in ongoing operation on a global scale. Over the course of multiple training sessions for Acino IT employees in Switzerland, Russia and the Ukraine, awareness was raised for IT quality processes. Beyond this, the ARCONDIS team provided the company with support, especially the IT-QMS manager in the initial phase after introduction. After all, our experience has shown that at the beginning especially, it is important to insist on complete, well thought-out execution of the new processes. With change requests, for example, a comprehensive assessment of all possible risks in case of system changes is essential, as is compliance with good documentation practice (GDocP) when creating documents. We not only actively guided this, consciously demanding compliance with processes, but also provided flexible assistance and focused on users, allowing us to ensure that the planned QM processes at Acino are established on a global scale and sustainable. From experience, successful IT quality management is based on a long learning process whereby the long-term benefit for users only becomes apparent over time.
Results & added value
The new, well-structured QM framework is lean and defines clear processes that can be implemented universally across the globe. The following also ensure added value:
- Inventory: The new, central CSV inventory establishes clarity with regard to the GxP relevance and status of all applications as well as the IT infrastructure.
- Reduction of SOPs: By reducing from 32 to 14 SOPs, the IT-QMS was eased, while users and managers were provided with considerable relief through the introduction of reusable templates. Training efforts were also decreased.
- Awareness: With the support of ARCONDIS for the roll-out and training sessions and beyond, the employees now feel confident in all things quality.
The customer was so impressed that ARCONDIS is now working on additional IT quality management projects for Acino. How did we manage this? It’s not just the results – Acino benefited during the entire course of the project! Thanks to flexible planning, ongoing IT operations were not interrupted, and no projects, services or go-live deadlines had to be postponed.
■ Verena Dreher
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