Welcome to the 6th edition of Mareana Deep Dive. This edition includes our updates from Dec 2025 and Jan 2026. Let’s have a look:

[White paper] 2026 Quality Assurance AI Playbook

We’ve updated our Quality Assurance AI Playbook for the year 2026. This version contains 8 AI powered use cases to accelerate batch release, eliminate the paper-digital limbo, and achieve inspection readiness without disrupting current operations. The framework provided in this playbook will help QA professionals unlock insights from their paper batch records, implement review-by-exception, and more.

👉 You can access the white paper here: 2026 Quality Assurance AI Playbook

2026 Quality Assurance AI Playbook

[White paper] 2026 Virtual Pharma AI Playbook

This is our new series of white papers specifically focused on Virtual Pharma Leaders. It provides 4 AI use cases to help virtual pharma manufacturers for digitization, faster release, and smarter investigations. It’ll facilitate better collaboration between sponsors and CDMOs.

👉 Check out this white paper here: 2026 Virtual Pharma AI Playbook

[Blog] Why Virtual Pharma manufacturers must digitize paper batch records and how they can do it with AI

In a model where manufacturing is outsourced to CDMOs, the batch record becomes the single most important document connecting product quality, regulatory compliance, and corporate oversight. Yet, despite advances in digital R&D, AI-driven discovery, and cloud-based quality systems, most virtual pharma companies still receive hundreds (sometimes thousands) of pages of scanned paper for every batch they sponsor.

This is no longer sustainable.

Digitizing paper batch records is not a “nice to have” IT upgrade—it is becoming a strategic and regulatory necessity for virtual pharma.

👉 Find out how virtual pharma manufacturers can digitize their paper batch records with AI

[Blog] How to implement review by Exception for faster batch reviews

The concept of Review by Exception (RbE) has long been the “holy grail” for speeding up this process, yet its implementation has remained challenging. For years, traditional OCR technology struggled with the variability of handwritten notes and complex paper templates, often creating more work than it saved. Other factors related to governance, validation, trust, risk, etc. also made OCR unreliable for batch reviews.

However, as AI technology has matured, the game has changed. Today’s AI can read handwritten paper records with high accuracy and analyze them to ensure they are not just legible, but correct.

👉 Learn how pharma manufacturers can adopt review by exception by leveraging AI

[Blog] The Future of Batch Review Software

Traditional batch review software can no longer keep up with the growing complexity of modern life sciences manufacturing. As data volume, system fragmentation, and compliance requirements increase, older tools fall short, resulting in slow batch release cycles, high manual workloads, and greater regulatory risk. Incremental fixes or additional staffing don’t solve the core issue: disconnected data and lack of automation.

👉 Read how AI is solving the problems that are difficult for traditional batch review software

[Industry Update] EMA and FDA released 10 Guiding Principles for AI in Drug Development

As AI adoption accelerates across the life cycle, regulators are shifting focus toward “Good AI Practice.”

👉 Learn more about the guiding principles released by EMA and FDA for using AI in drug development

[Product Update] Mareana Manufacturing Intelligence Platform is now live on Amazon Web Services (AWS) Marketplace.

This marks an important step in making it easier and faster for pharmaceutical manufacturers to adopt modern manufacturing intelligence.

Mareana solves a fundamental industry challenge by unifying fragmented manufacturing and quality data into a single, GxP-compliant source of truth.

By being listed on AWS Marketplace, pharma companies can now procure Mareana through a trusted, enterprise-ready channel. This means simplified contracting, faster vendor onboarding, secure deployment through AWS, and the ability to leverage existing AWS EDP commitments.

You can find our listing here: Mareana Manufacturing Intelligence on AWS

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