NOVEMBER 2023CIOAPPLICATIONSEUROPE.COM 19i2b is a Switzerland-based international consultancy specialized in IT project management, implementation, and providing support for computer systems validation (CSV) in the regulated life sciences sector. The company boasts over a decade of expertise in proposing and implementing practical solutions for businesses in the pharmaceuticals, biotechnology/biopharmaceuticals, medical device/scientific instruments, and chemicals industries."Whether it's complex divestment scenarios, SAP ERP projects or roll-out management, track and trace (T&T) implementations, or CSV services, our consultants have an extensive understanding of the specific business needs and requirements," says Rainer Streit, founder of i2b.During divestments, where a parent company sells off assets or subsidiaries, there is a crucial need to successfully localize and transfer existing centralized IT systems to the child organization. This necessitates a `clone and trim' strategy, where the parent company's systems are cloned and tailored to the operational needs of the new division.For example, if a large pharmaceutical company carves out a smaller division or product line, implementing the same level of processes, systems, and resources for the newly divested business could be cost-prohibitive. In these cases, refining the solution to meet the smaller business's needs while eliminating unnecessary aspects becomes the most viable option.However, accomplishing this transition within time, budget, and scope can often be arduous. i2b has a proven track record of executing product or site carve-outs within a limited timeline, ensuring the product or site is fully validated and operational from day one.Its dedicated CSV team excels at testing, validating, and meticulously documenting changes related to IT systems and processes. This documentation is paramount for organizations navigating shifts in their technological infrastructure.One of i2b's core competencies is SAP/MES consulting, which involves implementing traditional SAP roll-outs, encompassing various models within the ECC (Enterprise Core Component) and MDG (Master Data Governance) areas. It integrates data during these processes to ensure seamless data sharing and exchange among different systems and components.i2b also specializes in serialization for the pharmaceutical industry. Its comprehensive serialization program assigns a serial number to each saleable unit of a pharmaceutical product, allowing it to be tracked and traced back to its original source of supply. This provides a complete history of a product's chain of custody, preventing the risk of counterfeit and adulterated drugs, medicines, and other health products. i2b's serialization team assists clients in establishing strategies for implementing serialization and T&T, taking into account technical, management, and regulatory aspects.The company is also proactive in embracing pharmaceutical innovations and supports many organizations in integrating emerging technologies, such as blockchain, into IT and serialization systems. One notable example is its involvement with PharmaLedger, a European initiative aiming to deliver a blockchain-based platform for the healthcare sector.PharmaLedger decentralizes efficiently, prioritizing ecosystem stakeholders and adhering to emerging standards and regulations. This provides end-to-end connectivity and interoperability, allowing stakeholders from manufacturers to customers to verify a drug's source, development process, quality, and delivery conditions in a secure setting.Similarly, i2b has transitioned from following the waterfall model to adopting agile. During all client onboarding processes, the company's project methodology is underpinned by a clear organizational structure and an effective communication framework. However, what truly sets i2b apart is the wealth of experience of its GxP-trained team. Its expertise helps in comprehending industry intricacies, and through targeted training, it seamlessly adapts to the project specifics.Over the years, i2b has emerged as the leading consultant offering a spectrum of specialized services for IT projects in the life sciences industry. The company's commitment to these offerings sets the stage for enhanced operational efficiency, compliance, and success for its broad portfolio of clients in an ever-evolving landscape. Streamlining IT-Based Business Processes for the PharmaWhether it is complex divestment scenarios, smart tailor-made SAP ERP product solution integrations, track and trace implementations or computer systems validation our consultants have extensive understanding of the specific business needs and requirements RESOURCE PLANNINGSOLUTIONS PROVIDERS - 2023TOP 10ENTERPRISERainer Streit,Founder
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