Company insight
Making review by exception the rule
The pharmaceutical industry has long struggled to boost the efficiency of its batch review process. One solution that companies have been chasing with different degrees of success is digitally-enabled review by exception. To learn about the benefits, challenges and latest breakthroughs in this field we sat down with Aizon’s VP of product, Luiza Mukaeda, and program manager and industry specialist Donal McCarthy.
How has batch review traditionally worked in the pharmaceutical industry? Donal McCarthy: Batch review has always been a painstaking, time-consuming process. It involves manually sifting through stacks of documents to check for missing signatures, incorrect values, or anomalies. Any discrepancy can trigger a lengthy investigation, holding up batch release and increasing work-in-progress inventory. In lean manufacturing terms, it’s a process that is riddled with non-value-added steps. Customers expect quality, but they also expect efficiency. Time spent waiting for a batch record to be reviewed is time wasted – and that inefficiency comes at a cost.
Review by exception is a term that’s widely used, but not always in the same way. How do you define it? Luiza Mukaeda: It depends how broadly you define it. In theory, it refers strictly to the review of the electronic batch record. However, some consider review by exception to extend beyond the eBR to include all aspects leading up to batch release, such as lab results and supply chain data. At Aizon, we support both approaches with our cloud- based solutions: our product Aizon Execute enables review by exception up to the electronic batch record, while Aizon Unify expands that capability to include data from all relevant systems, providing a complete batch release context and even allowing users to customise screens to suit their specific review processes.
And what are the benefits of review by exception? DM: By shifting to a review by exception model, companies can eliminate a lot of the inefficiencies inherent in manual, paper-based systems.
Instead of discovering issues days later, users are alerted instantly when something goes wrong. This allows for quicker corrective actions, which can prevent delays in batch release and reduce the risk of non-compliance. The biggest benefit of this approach is the ability to improve speed and reduce the cost of review processes. Instead of sifting through hundreds of pages manually, quality teams can use the system to pinpoint exactly what needs attention. This not only speeds up the process but also reduces work-in-progress inventory, making the whole operation more efficient.
Many companies struggle to implement true review by exception. What are the main challenges? DM: One of the biggest challenges is overcoming the psychological hurdle. The pharma industry has been used to paper- based reviews for so long that there’s often resistance to change. Many people feel more comfortable manually checking each step, rather than trusting an automated system. LM: From a technical standpoint, creating a system that only shows relevant exceptions is also quite complex. The system needs to filter out noise and ensure that users are only seeing what truly matters. But the bigger challenge, as Donal mentioned, is the shift in mindset. Additionally, some manufacturers want to take the leap but are discouraged by the long timelines and the massive resource demands of traditional digital solutions.
How is Aizon tackling these challenges with the new Batch Release Cockpit? LM: We’re confident that we have built the industry’s first 100% review by exception system, integrating data from all necessary sources and providing an intuitive user experience that fosters trust in automation.
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
One key feature we’ve worked on is automated review flow suggestions. Instead of making users search for the next step, the system guides them, suggesting what to review next. This balances automation with human confidence: rather than asking users to blindly trust the system, we help them review faster and more efficiently. The other key aspect of our batch release cockpit is that it is, by far, the easiest to deploy and validate – it takes less than 100 days, which is dramatically faster than most alternatives. This makes these capabilities accessible to a much wider range of drug makers.
How does the new Batch Release Cockpit compare to MES-based solutions? LM: MES systems struggle with review by exception because they are too rigid. They have a single way of displaying information, making it difficult to adapt to different review processes. On the other hand, traditional electronic batch record solutions only cover the eBR, leaving gaps in the full batch release process. The Batch Release Cockpit changes this. By leveraging Aizon Unify, it integrates real-time data from production, labs, supply chain, and ERP systems, providing a truly comprehensive review experience. It allows companies to customise their review workflows, ensuring that every stakeholder has access to the right data in the right format. This is why we say it’s the first true 100% review by exception system – because it addresses the gaps that have prevented full adoption of the concept until now. With this solution, companies can finally move away from exhaustive manual review processes and embrace a faster, smarter, and more reliable approach to batch release. ●
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