About Isotopia
Isotopia is a global pharmaceutical company that develops, produces, and distributes cutting-edge diagnostic and therapeutic radioactive isotopes.
Isotopia offers advanced contract manufacturing services (CMO) that support all stages of product development under GMP conditions, requiring a strict quality system and close monitoring of any changes made to products, procedures, methods, work instructions for each department, and more. The demand for computerization and automation of processes has grown, leading regulatory bodies to reduce errors and product risks.
About Origami
Origami.ms, a no-code platform for the rapid creation of dynamic information systems, was chosen by Isotopia for its flexibility and ability to adapt to each customer individually. The Origami system allowed Isotopia to establish a customized, personal system that meets their specific needs and aligns with the high standards of leading pharmaceutical companies.
Challenges
The implementation of a digitization process for a GMP company like Isotopia posed several challenges. The compliance requirements, the need for multiple signatures and additional password protection, and the ever-increasing technical requirements made it difficult for both Isotopia and Origami. However, the two companies worked closely together to overcome these challenges and create an optimal yet flexible Origami environment.
Objectives
The main objective for Isotopia was to streamline their processes and improve their operations. The introduction of Origami helped in achieving this goal by digitizing all their paperwork and reducing the risk of anomalies and employee errors. Additionally, the implementation of Origami allowed for close monitoring and control in every issue, saving valuable working hours in the factory, and higher preparedness for audits. The solution not only provided logistical and ecological benefits but also allowed Isotopia to stay ahead of the competition.
The Process
The two companies worked together in a mutual learning process to create a high-quality interface that met the strict requirements of Isotopia. The GMP issue and unique requirements for the pharmaceutical industry posed a challenge, but the need for multiple signatures, additional password protection, and increasing technical requirements were addressed effectively.
The Origami platform completely replaced all paper-based processes, providing significant ecological and logistical benefits, including savings in paper, binders, storage spaces, and nylon. The system allowed for close monitoring and control of every issue, reducing anomalies and risk to the product, employee errors, and saving working hours in the factory.
The methodology and assimilation process were fast, as the software had an existing base and Isotopia made adjustments to see what was missing and what needed to be added or improved. The dashboard wizard within each module enables the creation of graphs, documents, and the monitoring of deviations. It also offers remote management of all users, pending tasks, tutorials, and more, providing a comprehensive and centralized view of all operations.
Origami’s support team was available at all times to support the implementation process, as well as the joint learning process in the factory. The two companies took the challenges posed by the GMP conditions and turned them into opportunities, providing Isotopia with a system that was optimized for their specific needs and Origami with the ability to guide and assimilate their learning about GMP quality systems for other customers.
Isotopia prioritizes their customers’ needs by adjusting their processes to fit their requirements. The dynamic and adaptable no-code platform offered by Origami enables GMP companies to streamline their operations and improve their processes, leading to improved audit preparedness and higher quality products for their customers.
Introduction of Additional Modules:
The implementation of Origami platform by Isotopia allowed for the creation of various modules, aimed at streamlining processes and improving the overall operations in a GMP company. The following are the key modules that were developed:
Exceptions: This module is designed to track and manage any deviations from the standard process.
Change Controls: The Change Controls module allows for the tracking and management of changes made to the processes.
Documentation Center: This module centralizes all the company’s documents and makes it easy to access and manage them.
Training: The Training module allows for the tracking and management of employee training and certifications.
Maintenance: The Maintenance module is designed to track and manage all maintenance activities in the company.
In addition to these modules, Isotopia also developed the OOS (Out of Spec) module independently, without requiring any assistance from Origami.
Advantages of the System:
The implementation of the Origami platform by Isotopia has resulted in numerous benefits for the company. One of the most significant advantages is the elimination of manual tasks and Excel sheets. Everything is now managed and tracked within the system.
Another advantage is the ease of accessing and managing documents. With the Documentation Center module, it is now possible to issue a copy of a controlled document with just a button press, without the need to visit the documentation center, make copies and seek approval and signatures from the responsible person.
This has greatly reduced the time and effort required for document management and has also contributed to the reduction of errors and anomalies in the company’s processes.
Origami’s support and collaboration
Origami’s support team played a crucial role in ensuring the successful implementation of the eQMS system at Isotopia. Their availability at all times during the implementation process, as well as the joint learning process in the factory, helped to address any challenges and provide solutions in a timely manner. The support team’s commitment to ensuring a smooth implementation process allowed Isotopia to focus on other aspects of their operations, confident in the knowledge that any technical difficulties would be resolved promptly by the Origami support team. This level of support greatly contributed to the success of the project and the satisfaction of both Isotopia and their clients.
Paperwork and Logistics
Origami was able to digitize and replace all the paperwork for Isotopia, resulting in significant savings in paper, binders, storage spaces, and nylon. This not only provides an ecological and logistical benefit, but also streamlines the process and reduces the need for manual intervention, resulting in increased efficiency and accuracy. With Origami’s software, all information can be easily stored and accessed in a secure and organized manner, which further helps Isotopia improve their operations and achieve better results.
Conclusion
The collaboration between Isotopia and Origami resulted in a successful implementation of a GMP-compliant eQMS solution. The Origami platform provided Isotopia with the flexibility and customization needed to streamline their processes and improve their operations. With the help of the Origami support team, Isotopia was able to address challenges and turn them into opportunities.
The end result was a system that digitized all paperwork, reducing employee errors and increasing efficiency in the factory. This success was recognized by the FDA, CE, and Israeli Health Ministry, who all audited and approved the implementation of the Origami platform as a GMP-compliant solution. The reduction of anomalies and risk to the product, close monitoring and control, saving of working hours in the factory, and higher preparedness for audits all demonstrate the positive impact this solution has had on Isotopia’s operations.
Visit Isotopia‘s website.
