Mareana Deep Dive Vol 7

Welcome to the 7^th edition of Mareana Deep Dive. This edition includes our updates from February and March 2026.

[Whitepaper] Oversight Without Control: A guide for Virtual Pharma Manufacturers

Virtual pharmaceutical companies face a critical structural trap: they bear total regulatory liability for their products but lack operational control over the manufacturing data generated by their Contract Development and Manufacturing Organizations (CDMOs). Relying on proprietary paper-based records and non-searchable PDFs creates severe data latency, forcing quality teams into retrospective damage control and manual transcription that introduces costly errors. This whitepaper explores how adopting a sponsor-side data intelligence approach allows quality and manufacturing teams to digitize, contextualize, and review CDMO data efficiently, transforming a high-risk hybrid system into an automated, audit-ready workflow.

You can access the whitepaper here: Oversight Without Control: A guide for Virtual Pharma Manufacturers

[Blog] How to digitize paper batch records with Mareana

Transitioning from manual documentation to a digital framework is a critical step toward ensuring data integrity and operational agility in the pharma industry. Industry research suggests that nearly 50% of all product quality issues are directly linked to human error during manual record handling. While the risks of manual paper records are well-documented, the primary challenge remains identifying a solution that is both technically robust and fully GxP-compliant. Mareana’s Manufacturing Intelligence (MI) platform addresses these needs by converting unstructured physical documents into a strategic digital asset.

Read how you can digitize your paper batch records with Mareana’s Manufacturing Intelligence Platform.

[Blog] CAPA Management with AI chatbots

AI chatbots are transforming how pharmaceutical manufacturers investigate deviations, perform root cause analysis, and manage corrective and preventive actions. Instead of relying on slow, manual investigations across siloed systems, AI-powered chatbots enable quality teams to analyze product genealogy, historical batch records, and operational data through simple natural language queries. This accelerates investigations, reduces CAPA documentation time, and helps organizations shift from reactive problem-solving to predictive quality management.

Read our blog CAPA Management with AI chatbots to dig deeper.

[Blog] Why Paper-Based CDMO Batch Records Are Now a Compliance Crisis for Virtual Pharma

Virtual pharmaceutical companies bear total regulatory liability for products manufactured by partners, yet rely on fragmented, paper-based data they cannot verify in real time. CDMOs provide papers and pdfs and the sponsors manually transcribe the data from these sources into digital format. This workflow is now flagged by the FDA as a high-risk practice, contributing to a 73% surge in enforcement actions.

Read Why Paper-Based CDMO Batch Records Are Now a Compliance Crisis for Virtual Pharma and prepare yourself for the changing landscape of pharma compliance.