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/ Mareana's Breakthrough

Manufacturing Intelligence,
Reimagined.

Mareana’s GxP-compliant platform transforms manufacturing data into insights and outcomes — optimizing production, accelerating releases, and ensuring quality.

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/ Unlock Your Edge

Key Benefits

Mareana has helped numerous firms in the Pharmaceutical, Chemical, Medical Device,
and Industrial Manufacturing industries achieve significant business outcomes:

Optimize Production

Optimize Production

  • Increase Yield
  • Shorten Cycle Time
  • Minimize Rejection Rate
Accelerate Releases

Accelerate Releases

  • Streamline Batch Review
  • Improve Right First Time (RFT) Rate
  • Expedite Deviation Resolution Time
Ensure Quality

Ensure Quality

  • Reduce Deviation Occurrences
  • Optimize CAPA Closure Rate
  • Minimize OOS Incidents

/ BATCH RELEASE COPILOT

AI-Powered Review By Exception

Batch Release Copilot uses AI to automate routine batch record checks, identify exceptions, and intelligently routes them to quality teams for review, ensuring compliant and efficient batch releases.

AI Scanning
Accelerate
Accelerate Batch Release

Cut batch review time in half by automating routine checks, empowering quality teams to focus on critical exceptions.

Reduce Error
Reduce Human Error

Automate 90% of batch parameters, allowing reviewers to concentrate fully on fewer items, significantly reducing human error.

Change Controls
Change Controls

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

21 CFR Part 11 and EU Annex 11
21 CFR Part 11 and EU Annex 11

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

AI Scanning
Shield

Good Manufacturing
Practice

Connected
Data Deep
Insights.

/ AI AUTOMATION

GxP By Design

Mareana makes compliance effortless, going beyond industry standards to support GxP 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.

Shield

Good Manufacturing
Practice

Connected
Data Deep
Insights.

/ ANY QUESTIONS? WE’D LOVE TO HELP

Frequently Asked Questions.

Mareana helps you modernize without disruption, reduce QA burden, and prepare every site for faster approvals. Our pre-built pharma data models bring manufacturing, quality, and lab data together out of the box.No custom development. Just visibility that drives smarter decisions, continuous improvement, and faster regulatory responses.

Mareana’s GxP-validated platform unifies manufacturing, quality, and R&D data to deliver real-time intelligence that empowers your team to work smarter—not harder. By automating batch release, digitizing paper records, and providing AI-powered root cause analysis, we help pharmaceutical manufacturers reduce risk, streamline audits, and accelerate approvals — all while maintaining the highest standards of regulatory compliance.

Being a GxP validated solution it works seamlessly with your existing systems—minimizing disruption, simplifying compliance management, and scaling effortlessly across multiple sites and partners.

Mareana is system-agnostic. It works alongside your existing infrastructure, integrating with SAP, Veeva, MES, LIMS, and more—no rip-and-replace required.

Our platform is built for life sciences and is compliant with 21 CFR Part 11 guidelines and global data protection standards. You get secure, validated workflows and audit trails from day one.

Our Batch Release Copilot flags only the critical exceptions that need human attention. The rest? Auto-reviewed, auto-routed, and fully traceable. The result: faster market access without compromising compliance.