01
Configure Once
Define products, parameters, limits, and chart types in one reusable configuration.
GMP Validated SPC
Turn Complex Pharma Data Into Actionable Intelligence
Mareana Charts is a GMP validated CPV and SPC platform for pharmaceutical manufacturing that automates chart generation, embeds Nelson and Westgard rules, and enables real time operational investigation workflows.
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Trusted by pharma &
life sciences teams at
life sciences teams at
We lose weeks
rebuilding charts for compliance and lose trust when moving fast with BI tools.
Mareana Charts brings
audit ready rigor and rapid investigation into one validated workflow
How Automated CPV Reporting Works in Mareana Charts
Built to eliminate manual reporting bottlenecks with a validated, automated workflow for faster, audit ready CPV reporting.
02
Auto-Ingest Data
Pull contextualized data directly from LIMS, MES, and ERP systems without manual extraction.
03
Apply Validated Statistics
Automatically execute SPC rules, Westgard checks, and CPK calculations using validated logic.
04
Schedule & Monitor
Generate version controlled reports with automated alerts and rule-based routing.
From Detection to Action
Mareana Charts connects SPC rule detection, automated alerting, and owner-level response in a single traceable workflow turning statistical signals into immediate operational action.
Real Time SPC Monitoring & Alert Routing
Detects Nelson Rule violations directly inside live SPC charts and automatically routes contextual alerts to the responsible owner connecting chart, signal, notification, and action in a single validated workflow.
Preset Driven Statistical Configuration
Start with predefined product risk tiers, then expand into fully traceable Nelson and Westgard rule configurations giving quality teams a faster path to standardized, audit defensible SPC monitoring.
Configurable Nelson, Westgard and WECO Rules for Early Drift Detection
Enable early process drift detection with a validated library of Nelson Rules 1-8, Westgaard rules, and WECO rules, configurable by parameter and risk tier.
- Early detection of process drift
- Validated rules, ready to use
- Automated alerts & notifications
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Advanced SPC & Quality Charts
Visualize deviations, process stability, variability, and operational trends through interactive statistical analytics designed for pharma manufacturing.
Bar Chart
Compare counts across batches, lines, or departments.
Box Plot
Identify spread, median shifts, and QA outliers instantly.
Distribution Chart
Visualize data distribution and understand process variation.
Process Control
Detect process drift and control limit violations in real time.
Histogram
Understand data distribution and process performance.
EWMA Chart
Monitor small shifts in the process mean with greater sensitivity.
Heatmap
Identify high-impact areas and patterns at a glance.
Line Chart
Track process trends and stability across batches.
Scatter Plot
dentify outliers, process drift, and variability across batches and process parameters.
21 CFR Part 11 Compliance: Native Version Control, Change Control, and Audit Traceability
Every Mareana chart object carries native version history, electronic approval workflows, and an immutable audit trail recording user, timestamp, and configuration. Auditors can reproduce any historical chart used in a prior APR or PQR without forensic spreadsheet archaeology.
Immutable Audit Trail
Every action is recorded
Electronic Signatures
21 CFR Part 11 Compliant
See Something Unusual?
Ask Lumis.
Lumis helps teams investigate anomalies, compare batches, and uncover root causes directly from their charts.
Every response links back to the source:
SPC events & rule violations
MES batch execution records
LIMS analytical results
Equipment & maintenance logs
Historical process baselines
Cross site CPV trend comparisons
Want to see Lumis investigate a real CPV signal?
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Connect LIMS, MES, and ERP Systems Without a Data Lake
Mareana Charts connects directly to existing manufacturing systems through pre built connectors, transforming raw operational data into CPV ready insights without manual data consolidation or complex infrastructure projects.
LIMS
ERP
MES
HISTORIAN
REST APIs
Custom Connectors
Database Adapters
Real Outcomes From Real Manufacturing Teams
From CPV reporting to OOT detection, quality organizations are transforming how they monitor, investigate, and release products.
90%
Reduction in CPV Reporting Effort
Hours
Instead of Days for Investigations
21 CFR Part 11
Compliant by Design
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Got Questions?
We’ve Got Answers.
Configure once, then automatically generate audit ready SPC reports from connected pharma systems.
Yes. Mareana Charts provides validated SPC analysis with Nelson and Westgard rules built in, eliminating the need for separate statistical tools while maintaining full compliance traceability.
Automated Nelson and Westgard rule monitoring detects process drift in real time, routing contextual alerts to responsible owners before issues escalate to OOT events.
Every chart carries native version history, electronic signatures, and an immutable audit trail recording user, timestamp, and configuration changes — fully aligned with 21 CFR Part 11.
Need More Information?
Connect with our experts to learn how Mareana Charts helps pharma teams automate SPC monitoring, detect process drift early, and stay inspection ready.
Ready to Modernize Pharma QA Analytics?
Transform deviations, SPC monitoring, and quality insights into actionable decisions with real time visual analytics built for regulated manufacturing.
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Book a Demo
