AI-Powered Manufacturing Intelligence

Go from data overload to decisive action. We harmonize your complete manufacturing landscape, from legacy paper to real-time process data, to accelerate batch releases, predict quality events, and fortify compliance at every stage.

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Customers Who Trust Us

Chat With Your Manufacturing Data

Explore your manufacturing data using natural language. Ask questions, surface insights, investigate deviations, and even generate charts. It's like having a data scientist, historian, and process expert in one conversational interface.

Accelerate Investigations

Uncover Hidden Insights

Ask complex questions in plain English

Batch Release Copilot

AI-Powered Review by Exception

Batch Release Copilot transforms your most significant compliance bottleneck into a strategic advantage. Our AI-assisted solution turns manual batch record review into an intelligent, exception-only workflow, empowering your team to release products days faster while minimizing errors and guaranteeing compliance.

Focus expert judgement only on true exceptions

The End of APQR Season

Automate your Annual Product Quality Review using harmonized data from across every system. With a single click, generate a compliant, audit-ready APQR (complete with trend analysis and deviation categorization), freeing your team from months of manual work.

Slash APQR generation time from months to hours.

Identify quality trends proactively, not retrospectively.

Liberate your experts for strategic quality initiatives.

And there’s more...

Mareana has all the tools you need to optimize production, accelerate releases, and ensure compliance.

Genealogy

Transform fragmented manufacturing data into a complete, visual batch history, enabling instant recall response, simplified investigations, and guaranteed GxP compliance.

Paper Batch Record Digitization

Unlock legacy data from paper to accelerate batch release and ensure GxP compliance.

Data Science Studio

AI-powered analytics and no-code ML for immediate insights, optimizing manufacturing processes.

Smart CPV

Anticipate quality deviations before they impact your batch, using predictive analytics to reduce investigation costs, ensure compliance, and protect product quality.

Who is Mareana for?

  • Quality
  • Manufacturing
  • Regulatory
  • MSAT
  • IT

Unified Quality: Corporate Strategy to Site Control

Connect corporate strategy with daily execution to drive predictable quality and empower your team with unified, compliant data.

  • Unify data into one source of truth. Automate APQR and site reports, freeing teams for high-value analysis while ensuring GxP compliance and constant audit-readiness.
  • Slash batch release cycles from weeks to days with AI-powered review. Empower teams to make faster decisions and accelerate time-to-market for your critical products.
  • Shift from reactive fixes to proactive control. With real-time process monitoring, your teams can correct drifts before they escalate, reducing costly rework and lowering enterprise risk.

GxP by Design

Mareana makes compliance effortless, going beyond industry standards to support cGxP best practices. With built-in validation protocols, we take the heavy lifting off your plate, delivering secure access, e-signatures, and audit trails right out of the box.

Software Development

Mareana follows an SDLC process that has been audited by the largest life sciences brands in the world.

Installation & Configuration

We make it simple to validate and maintain with vendor-supplied IQ, OQ, PQ protocols.

Change Controls

Use of multi-tiered environment for major changes and patches.

21 CFR Part 11 & EU Annex 11

Mareana delivers compliant capabilities out of the box like secure user access, e-signatures, and audit trails.

Mareana Resources

Life sciences manufacturing best practices, original research, news and more

Blog Mareana Deep Dive Vol 8 Learn More](/content/blog/mareana-deep-dive-vol-8/index.html)

Blog Three Paths to Faster Batch Review: Beyond the Enterprise MES Assumption Learn More](/content/blog/three-paths-to-faster-batch-review/index.html)

Blog Manual Batch Record Review: Hidden Costs and Compliance Risk Learn More](/content/blog/manual-batch-record-review-pharma/index.html)

Blog AI In Pharma Manufacturing: A Deep Dive Learn More](/content/blog/ai-in-pharma-manufacturing/index.html)

Blog How Virtual Sponsors Are Solving the CDMO Batch Record Problem from Their Side Learn More](/content/blog/how-virtual-sponsors-are-solving-the-cdmo-batch-record-problem-from-their-side/index.html)

8 AI use cases to transform your quality assurance.

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