Aizon FAQs

Yes, you can access all your data through a bidirectional REST API. This allows you to extract data for use in other systems while ensuring data integrity. However, importing data back into the Aizon platform is not always possible to maintain this integrity. For specific use cases, we can develop gateway applications that allow controlled data input via API, ensuring a secure and compliant environment.

Both Execute and Unify are cloud-based, making it easy to create user accounts for your customers. Aizon allows you to establish policies that limit the information customers can access and specify the activities they can perform. Additionally, you can whitelist IP addresses to further secure data access. You can monitor all users centrally and manage access using your own identity server for enhanced security and compliance. This ensures controlled data sharing, regulatory compliance, and tailored access, providing transparency while maintaining data integrity.

Yes, two users can execute the same recipe on Execute, but they cannot concurrently work on the same phase of the recipe. Additionally, you can enforce such restrictions through policy and workflow configurations, ensuring proper coordination and preventing conflicts during execution. This setup helps maintain process integrity and efficiency.

In Execute, a recipe cannot be deleted once it is released. It can only be deleted while it is in draft status. If a draft recipe is deleted, this action is tracked in the activity trace and is fully auditable, ensuring compliance and transparency.

At Aizon, we employ a holistic approach that encompasses all our company procedures, tailored specifically for the pharmaceutical industry. Born to serve this sector, we deeply understand, comply with, and provide guidance around Good Manufacturing Practices (GMP).

Our compliance strategy is structured around four key pillars:

1. Aizon Quality Management System (QMS):
   • We adhere to strict quality and security certifications, including ISO 27001/17 & 9001.
   • We ensure audit readiness to meet regulatory demands efficiently.
2. Infrastructure Qualification:
   • Our solutions are cloud-native and focus on robust information security.
   • We manage user profiles and access to maintain secure operations.
   • We implement risk monitoring and control alongside change control and audit trail processes.
3. Data Lifecycle Management:
   • We ensure compliant and patented data acquisition methods.
   • We manage regulated data lakes and data processing while maintaining data integrity and traceability (ALCOA+).
   • Our processes include electronic signatures to enhance security and compliance.
4. AI & Application Lifecycle:
   • We manage AI applications, ensuring continuous monitoring, optimization, and validation of AI models.
   • Our AI algorithms are qualified to meet industry standards and regulatory requirements.

By integrating these components, we ensure our pharmaceutical clients not only meet but exceed regulatory standards, enhancing compliance, quality, and operational efficiency.

Our solutions can usually start delivering tangible results within a six weeks time frame, thanks to our tailored approach and the Aizon Consulting Services team. Typically, projects begin with an exploration phase to fully understand the ecosystem, stakeholders, and define an implementation path. Then, the timing will very much depend on the project type:

Execute:

• We usually deploy an environment within two weeks.
• Following deployment, the tool is customized, and users are trained.
• The entire project is typically completed in about 6 to 12 weeks.
• Additional layers of complexity, such as connecting APIs or apps, might extend this timeline.
• Comprehensive customer support is available throughout the implementation and ongoing production processes

Unify:

• Our priority is to address specific problems. We first understand the data required to improve the process, rather than just connecting all the available sources.
• The solution is then tailored, and your team is trained to maximize its benefits. This phase usually takes between 8 and 12 weeks.
• We then expand the scope by integrating additional data, solving new problems iteratively to add value in short windows.
• Timelines can be impacted by security protocols and complexity of system architecture

Predict:

• The timeline depends on the complexity of the problem being solved with AI.
• If Unify is already in place, it takes about 2 to 3 months.
• If starting from scratch, the process may take longer, usually between 4 and 6 months.

These timelines provide general guidance and demonstrate how our approach can favorably impact ROI/NPV calculations.

Aizon Unify and Predict are designed with scalability in mind, ensuring they can grow and adapt alongside your operations. They can handle increasing data volumes, integrate new data sources, and support additional users as your manufacturing, quality, and other operational needs expand. The platform's flexible architecture allows for easy configuration and customization, accommodating changes in processes and compliance requirements. This ensures that your investment remains future-proof, providing continuous value as your business evolves.

We provide comprehensive support and training to ensure your team is fully onboarded and ready to use our solutions effectively. Our services include:

1. Implementation Support: Dedicated support during the setup and integration phase to ensure a smooth transition.
2. Initial Training: Customized training sessions tailored to your team’s needs, covering all aspects of our platform.
3. Train-the-Trainer: We equip key team members with the knowledge and skills to train others within your organization.
4. Ongoing Assistance: Continuous support through our helpdesk, including troubleshooting, updates, and additional training as needed.
5. Partner Network: Access to our network of authorized partners for additional consulting and implementation services.

Our pricing model is tailored to each client, based on company type and expected ROI, ensuring cost efficiency. The main factors considered include the number of sites and their complexity. In addition to the software cost, we charge for implementation or consulting services. However, you have the option to choose from any of our authorized partners for these services. This transparent approach ensures there are no hidden fees or unexpected costs.

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No, it's not. Execute is not a traditional Manufacturing Execution System (MES). While it covers the Electronic Batch Records (EBR) block extensively with features like recipe creation, conversion, validation, lifecycle management, execution, auditing, analytics, and review by exception, it does not encompass all typical MES functionalities such as inventory management, quality management, or equipment logs.

For these additional functionalities, Execute integrates with existing systems like ERP, QMS, LIMS, and DCS, allowing you to choose and maintain the best-in-breed solutions for each area. This open platform approach ensures data sharing and interaction with top-tier solutions, leading to a quicker time to value with smaller, less risky implementations compared to multi-year, high financial risk projects.

Importantly, with Execute, it’s your data, and you have full access to it, ensuring transparency and control. By focusing on EBR and integrating with other systems, Execute provides a flexible, scalable solution tailored to your specific needs while leveraging existing infrastructure.

Invest in what you need, don't pay for what you don't.

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