Digitalizing Batch Records in Pharmaceutical Production with Aizon

By Gokhul Srinivasan, Sr.Partner Solutions Architect – AWS
By Lluis Solanes, Marketing Director – Aizon

Aizon

Pharmaceutical manufacturing leads digital innovation with robotics and automation in producing life-saving medicines. Yet, pharma manufacturers rely on paper-based batch records, while quality specialists drown in manual documentation reviews. Pharmaceutical companies today face a critical challenge: manual documentation processes that slow innovation, increase compliance issues, and prevent real-time decision-making.

A single missing signature delays batch release by days. Illegible handwriting introduces data interpretation errors. Storage costs mount as regulations mandate retaining records for years. This outdated, paper-heavy process creates operational inefficiencies and data silos, limiting manufacturers’ ability to optimize processes and reduce costs. The lack of accessible data prevents proactive decision-making.

Recognizing these challenges, Aizon, an AWS Partner Network Advanced Technology Partner, offers a solution: Aizon Execute, an intelligent Batch Record (iBR) SaaS platform. With Aizon Execute, drug manufacturers digitize their batch management and unlock the value of their production data. This blog explores how customers implement Aizon Execute in 45 days to digitize batch records, accelerating compliance and operational efficiency.

The Hidden Costs of Paper-Based Manufacturing: A $250B Opportunity Gap

The financial and operational impact of maintaining paper-based systems extends beyond the apparent costs of paper and storage. Digitization reduces manufacturing costs by 20-30%, with a manual review of paper batch records taking 2-3 hours per record. Let us break down the cost drivers:

Inventory Impact:

• Pharma inventory levels equal to net income. Every $1 million in profit, locks $1 million in inventory.
• Documentation delays can freeze millions in working capital. A 10% speed improvement potentially unlocks $800M in inventory savings.

Operational Inefficiencies:

• Operators spend 30% of their time on paper documentation instead of focusing on business priority tasks.
• 1% deviation rates can disrupt production timelines and impact supply chain efficiency.
• Multiple data entry points increase error risks, leading to compliance impact and rework.

Lost Opportunities:

• Of the $250 billion total AI opportunity across the drug lifecycle, $100 billion potential is in manufacturing optimization.
• Anticipating issues through AI-driven decision-making helps manufacturers eliminate deviations before they occur, rather than reacting to costly errors after the fact.

By transitioning to digital oversight, manufacturers can boost production, save resources, and strengthen supply chain resilience.

Aizon’s AI-Powered Manufacturing Stack

Aizon’s tech stack includes machine learning (ML) applications for quality management, yield optimization, root cause analysis, and Artificial Intelligence (AI) model validation and lifecycle management. Aizon empowers drug makers with its manufacturing optimization stack:

• Aizon Execute: Automatically digitizes paper-based batch records and establishes robust workflows to reduce deviations, speed up batch releases, and anticipate decision-making.
• Aizon Unify: Integrates and contextualizes manufacturing data for real-time monitoring, actionable insights, and audit readiness. Unify breaks down data silos, and streamlines complex analytics across processes, systems, and sites.
• Aizon Predict: Industrializes AI models in GxP environments to enable predictive analytics, improve yields, reduce deviations, and facilitate proactive maintenance.

Aizon scales from pilot facilities, processing 10 batches monthly to enterprise plants managing 1,000+ batches annually. Real-world examples include how a pharma saved $30M with Aizon Unify and how a global biotech decreased pooling time by 93% with Aizon Predict.

Aizon Execute Architecture

Built on AWS-native, serverless architecture, Aizon Execute provides every customer with a dedicated single-tenant environment for enhanced security and privacy. Aizon Execute adheres to the AWS Well-Architected Framework, leveraging a comprehensive suite of AWS services for storage, compute, compliance, security, and infrastructure, such as:

• Amazon DocumentDB, Amazon Simple Storage Service (Amazon S3), Amazon DynamoDB for data storage.
• Amazon Kinesis Data Streams, Amazon Data Firehose, and Amazon Simple Queue Service (Amazon SQS) for data intake and processing.
• Amazon API Gateway for integration and AWS Lambda for compute.

Transforming Batch Records: Inside Aizon Execute

Aizon Execute is designed to support GxP compliance, offering scalability and better performance while lowering operational costs. Its pragmatic approach, addresses the pharmaceutical industry challenges through three integrated components that deliver immediate value while building digital maturity.

Core Capabilities:

• Automated iBR digitization to minimize the largest source of controllable variability (human intervention) and seamless, collaborative tool for new recipe creation.
• Rapid change management, with key user adoption in hours, not weeks, thanks to a digital iBR that mirrors the original recipe and an intuitive UI/UX.
• Tangible outcomes from day 1, accelerating batch release time and unlocking actionable process data.

Aizon Execute’s architecture combines three essential layers: The Manager for administrative control and recipe management, the Integration layer for secure data exchange, and the Executor for shop-floor operations. This provides the foundation for continuous improvement through data-driven insights.

Figure 1. Architecture overview of Aizon Execute

Achieving Compliance Excellence: Aizon Execute’s Digital Workflow

Aizon Execute digitizes paper-based manufacturing recipes and features drag and drop electronic workflows. Execute maintains version control of recipes, captures electronic signatures, standardizes procedures across multiple production sites through centralized recipe management, and audit traces recipe execution.

Execute guides the operator with these digital workflows, ensuring consistency and precision through advanced rules enforcement; it creates electronic signatures for operators and reviewers, captures timestamps and maintains an audit trail. Quality managers configure requirements and acceptance criteria, while operators benefit from clear, step-by-step guidance that helps support GxP compliance through built-in controls.

Figure 2. Execute Workflow: Enforce rules and parallel activities through an intuitive interface

The Process Orders dashboard aggregates batch records into a single view, reducing review time from days to hours by providing real-time production monitoring. It standardizes workflow strengthening quality control, maintains version control across master recipes, generates audit trails, and eliminates paper handling, reducing documentation errors.

Figure 3. Visualize process orders with an integrated view across all plant sites

The Activity Trace dashboard delivers compliance monitoring by capturing every system interaction in real time, creating a chain of evidence. It offers a searchable digital log that tracks user identity, exact timestamps, actions performed, and electronic signature verification.

Figure 4. Execute activity trace feature for compliance management

Customer Roadmap to Measurable Results: a 100-Day Digital Transformation

Aizon’s structured and proven approach delivers measurable outcomes within the first year of implementation. Transitioning to digital operations delivers incremental value through a carefully orchestrated timeline. Here’s how Aizon structures this journey for maximum impact and minimal disruption:

• First 45 Days: Manufacturers see their first breakthrough by getting rid of paper and unlocking production data. Aizon Execute helps reduce review time, eliminates manual errors and delivers immediate improvements in compliance and efficiency.
• First 90 Days: Aizon Unify makes real-time, data-driven decisions available by integrating and contextualizing manufacturing data. This offers complete transparency across operations, leading to efficient analytics and better operational monitoring.
• First 100 Days: Aizon Predict helps optimize processes with predictive analytics powered by AI, driving yield improvements, reducing deviations, and ensuring GxP compliance.

Unlike traditional electronic batch record (eBR) implementations that can take years to show results, this accelerated approach delivers measurable improvements within weeks. The journey maintains regulatory compliance while progressively introducing more sophisticated capabilities, ensuring both immediate wins and long-term value creation.

From Paper to Digital Pioneer: Euroapi’s Success with Aizon Execute

Euroapi, a leading European pharmaceutical manufacturer, recognized an opportunity to modernize its pharmaceutical operations. Their manufacturing floors are effective, but the paper-based process affects their efficiency. Quality specialists spent hours reviewing paper records, preventing real-time analysis and optimization.

“At Euroapi, we are committed to leveraging cutting-edge technology to enhance our manufacturing processes and deliver the highest quality products made in Europe to our customers” said David Seignolle, Chief Executive Officer of Euroapi. “Existing eBR options do not match the realities of how APIs are manufactured today.”

Euroapi found their answer in Aizon Execute. The collaboration began with a clear vision: create a lightweight, purpose-built solution that delivers immediate results while laying the foundation for future improvements. Unlike traditional implementations that take years, Aizon had the initial system running in six weeks. Freed from manual documentation, operators, quality leaders and process engineers focus on high-value tasks. Real-time data visibility allows proactive decision-making, and automated compliance checks ease quality control.

David Seignolle explains, “Our collaboration with Aizon to design a lightweight, purpose-oriented, and essential eBR, represents a pivotal step in our digital transformation journey, with our vision to streamline and optimize our processes. We chose Aizon as our collaborator because of their flexibility and proven track-record in pharmaceutical data management. We are excited about the potential this innovative solution holds.”

Aizon Execute’s role in Euroapi’s success highlights its capability to connect traditional manufacturing and digital innovation, establishing a competitive advantage.

Conclusion

For the pharmaceutical industry, digital batch record management is essential for competitive success. The reliance on paper-based processes creates operational bottlenecks, compromises data integrity, and slows time-to-market for vital medicines. Built on Amazon Web Service (AWS), Aizon Execute solves these challenges with its lightweight, user-centric platform that integrates with existing operations. By combining iBR with real-time data, manufacturers reduce review times and eliminate manual errors in just 45 days.

Take the first step toward digital transformation: visit aizon.ai to learn more about Aizon’s solutions, and schedule a personalized demo to discuss how to solve your specific manufacturing challenges.

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Aizon – AWS Partner Spotlight

Aizon is an AWS Advanced Technology Partner and AWS Competency Partner that transforms manufacturing operations using advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within highly regulated industries. Aizon offers an intuitive way to gain meaningful operational intelligence by enabling real-time visibility and predictive insights in a GxP compliant manner.

Contact Aizon | Partner Overview | AWS Marketplace