In the pharmaceutical and life sciences industries—and in general in regulated environments—data integrity is essential. In the sectors that IMA Group addresses, there are many complexities and critical issues. They are very different from each other, and all must be given a solid and reliable solution that delivers the highest quality and compliance of the final product.
IMA’s company slogan is: “Different markets. One flexibility on a global scale.” IMA designs, develops and manufactures machines for the production of solid oral forms, both in traditional batch mode and in the promising continuous manufacturing.
With continuous growth in mind, digitization of processes is important. The IMA Active portfolio includes more than 28 families of machines and systems for process, product treatment and washing, each of which has various sizes and a considerable degree of customization.
The first essential point to be addressed when adopting a technology in the pharmaceutical field, is the management of data integrity. Without data, a lot of product is often discarded.
Data integrity can be defined as the guarantee that a set of data is correctly managed during the production process and in relations to all operational areas, including production, laboratories and warehouses.
To be considered healthy, data must meet various criteria throughout its lifecycle.
The U.S. Food and Drug Administration provides for criteria that address five data qualities: attributable, legible, contemporaneous, original and accurate. In addition, the data must be complete, consistent, enduring and available.
Software technologies that natively support and manage these requirements in a standardized way can be a great support in the system validation process.
A historian solution, for example, can allow, through its collector system, a process to generate data records already associated with identifiers like product and lot.
It can then time stamp and send them, in a secure-by-design and encrypted manner, to a storage server.
The data record, once generated, cannot be changed without codified procedures and is completely compatible with the reference legislation.
Connected data can be a key enabler of better business performance and can help to meet the stringent needs of regulatory bodies. An enterprise-wide industrial data solution collects and analyzes data—and then automates and integrates the information related activities of the plant for performance optimization holistically.
With these capabilities, operators can make objective business decisions related to efficiency, downtime and quality.
To provide visibility, plant-floor data is collected from controllers, such as PLCs, with redundant collectors and stored in a historian solution preventing data loss in case of disconnection.
Data stored in a central historian provides a single version of the truth, and through analytics, manufacturers can see trends and understand the impact of making changes.
Data analysis brings deep operational insights that might have been previously untapped.
The software solutions used by IMA Active provide 100 percent data integrity and easy customization for its global customer base. And, the historian technology in their system can secure a cost-effective, flexible way to collect data and have it available for future needs.
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