Discover real-world case studies, actionable strategies, and practical frameworks to integrate AI into quality operations. 

The essential guide to AI quality assurance

31%

Reduction in deviation investigation time

63%

Reduction in root cause analysis efforts

50%

Reduction in batch review time.

Batch Release Copilot. From manual review to "review by exception"

50% Faster Batch Review

Minimize batch failures and investigations

AI-driven insights help identify and prevent deviations before they happen, reducing costly rework and delays. 

AI-powered batch review eliminates tedious manual checks, allowing quality teams to focus on critical exceptions.

AI-powered root cause analysis connects historical data, reducing time spent on investigations and improving corrective action effectiveness.

Experience the Future of Pharma Manufacturing

Mareana solves what others struggle with, instantly with AI-Powered Manufacturing Intelligence.  

Request a Demo

Reduce review time from weks to days

Ensure faster regulatory compliance

Request a Demo
FAQ Section
Q: How does AI accelerate batch review?

A: AI validates 80% of batch parameters instantly, flagging only critical exceptions for expert review. This eliminates manual cross-checking, reducing review times by up to 50%.

Q: Can AI prevent deviations before they occur?

A: AI detects process variations in real time, correlates with historical trends, and alerts teams before deviations lead to quality failures.

Q: How does AI speed up CAPA resolution?

A: AI automatically links current deviations to historical CAPAs, providing instant root cause insights and reducing investigation cycles.

Q: How does AI prevent recurring quality issues?

A: AI identifies patterns in past CAPAs and suggests process adjustments, reducing the recurrence of quality deviations.

Q: Is AI compliant with GxP and 21 CFR Part 11?

A: Yes, AI maintains audit trails, enforces electronic signature validation, and ensures full traceability for regulatory compliance.

Q: How does AI support regulatory audits?

A: AI automatically compiles quality data, deviation history, and batch records, reducing audit preparation time and ensuring compliance.

Q: Can AI-generated decisions be overridden?

A: Yes, AI provides transparency in decision-making, allowing human intervention when necessary while maintaining compliance records.

Q: How does AI ensure data integrity in batch records?

A: AI captures all actions, enforces access controls, and provides immutable audit logs, safeguarding against data manipulation.

Q: Can AI help standardize quality review processes?

A: AI enforces predefined quality rules, ensuring uniform application of standards across all batch reviews and regulatory documentation.

Q: How does AI reduce quality review workload?

A: AI automates data validation, reducing time spent on repetitive reviews and allowing quality teams to focus on high-risk cases.

Q: How does AI help reallocate quality team resources?

A: By automating routine checks, AI allows experienced personnel to focus on strategic quality improvements and process optimizations.

Q: How does Mareana integrate with existing systems?

A: Mareana seamlessly connects with MES, QMS, ERP, and LIMS, ensuring interoperability without disrupting workflows.

Q: How long does AI deployment take?

A: Implementation timelines vary but typically range from weeks to a few months, depending on system complexity and data readiness.

Q: Does AI require extensive training for quality teams?

A: AI-driven workflows are designed for intuitive use, requiring minimal training while enabling faster adoption.

Frequently asked questions

Identifies potential issues before submission, preventing rework and costly delays.

AI automates routine checks and flags only exceptions for human review.

Ensures that every batch meets regulatory requirements with AI-powered verification.

GxP-Compliant AI Validation

Reduces Compliance Risk

Complete Decision Traceability

Ensures end-to-end decision traceability for compliance, quality, and regulatory confidence 

Mareana integrated effortlessly with our systems, enhancing efficiency and compliance with unmatched accuracy. Highly recommended

VP of Manufacturing, Leading Biotech Firm

Mareana’s AI-driven solutions have streamlined our batch release process, ensuring compliance and reducing approval time. A game-changer 

Quality Assurance Director, Global Pharma Company

Boosting efficiency, ensuring compliance, and speeding 
up batch releases. 

See how AI helps quality teams cut batch review times, improve Right-First-Time rates, and resolve CAPAs faster.

Traditional quality assurance can’t 
keep up with the industry's demand 
for speed and compliance.

Slow batch reviews, high deviations, and CAPA delays create costly bottlenecks and regulatory risks. AI-powered solutions help quality leaders streamline processes and accelerate product release. 

Download the guide

• Halve batch review times with automated workflows. 

• Boost Right-First-Time rates with predictive insights. 

• Speed up CAPA resolution with AI-driven root cause analysis.

The essential guide to AI quality assurance

Boost efficiency, ensure compliance, and speed
up batch releases. 

Discover real-world case studies, actionable strategies, and practical frameworks to integrate AI into quality operations.

50%

63%

63%

33%

Faster scale-up studies

Reduction in deviation investigation times

Reduction in regulatory report preparation time

Reduction on review times

Watch the Impact: Real Results with  Mareana’s AI-Assisted batch release

Watch the Impact: Real Results with  Mareana’s AI-Assisted batch release

63%

50%

31%

Reduction in deviation investigation time

Reduction in root cause analysis efforts

Reduction in batch review time.

Download the guide

Traditional quality assurance can’t 
keep up with the industry's demand 
for speed and compliance.

Slow batch reviews, high deviations, and CAPA delays create costly bottlenecks and regulatory risks. AI-powered solutions help quality leaders streamline processes and accelerate product release.

Ensure faster regulatory compliance

Reduce review time from weks to days

Minimize batch failures and investigations

AI-powered batch review eliminates tedious manual checks, allowing quality teams to focus on critical exceptions.

AI-powered root cause analysis connects historical data, reducing time spent on investigations and improving corrective action effectiveness.

AI-driven insights help identify and prevent deviations before they happen, reducing costly rework and delays.

Download the guide

Mareana solves what others struggle with, instantly with AI-Powered Manufacturing Intelligence.  

Experience the Future of Pharma Manufacturing