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Power Your Bioanalytical Workflows with Precision & Compliance

End-to-end bioanalytical software for BA/BE studies—from sample import to regulatory submissi on, ensuring complete traceability, automation, and data integrity.

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21 CFR Part 11 Ready
21 CFR Part 11 Ready
GLP / GCP Compliant
GLP / GCP Compliant
LC-MS/MS Integration
LC-MS/MS Integration
End-to-End Traceability
End-to-End Traceability

About bioanalytical solution

Zentixs Alpha is a comprehensive platform designed to digitize and streamline bioanalytical operations across BA/BE studies. From study design and sample management to PK analysis and reporting, the system ensures accuracy, efficiency, and compliance at every stage.

  • Manage and build flexible study designs
  • Upload sample manifests using smart templates
  • Reduce metadata transfer errors through protocol integration
  • Achieve full traceability across study lifecycle
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Key Value

Transform manual, error-prone processes into a fully automated, audit-ready workflow.

Powerful Capabilities Designed for Bioanalytical Labs

A complete suite of tools to manage every aspect of your bioanalytical workflow with precision.

Study Design & Management
Study Design & Management
  • Model flexible study designs and amendments
  • Protocol-driven configuration
  • Centralized study lifecycle control
Sample Management & Chain of Custody
Sample Management & Chain of Custody
  • Upload sample manifests via templates
  • Track sample shipments and movements
  • Define storage down to plate position level
  • Track freeze/thaw cycles and stability
  • Generate audit-ready chain of custody
Instrument Integration
Instrument Integration
  • Seamless integration with LC-MS/MS systems
  • Automated data capture (no manual entry)
  • Bi-directional communication with instruments
  • Compatible with SCIEX, Waters, Agilent
Data Processing & Analysis
Data Processing & Analysis
  • Automated concentration calculations
  • Regression models (linear/non-linear)
  • PK/TK analysis and bioavailability calculations
  • ADA / Immunogenicity workflows
Reassay & ISR Management
Reassay & ISR Management
  • Identify reassays automatically
  • Track Incurred Sample Repeats (ISR)
  • Automated reassay decision workflows
Reporting & Data Export
Reporting & Data Export
  • Generate full study reports
  • Export in CDISC, SEND, SDTM formats
  • Customizable client-specific reporting
Quality & QA Review
Quality & QA Review
  • Real-time data quality snapshots
  • Faster QA review cycles
  • Pre-defined assay performance tables

End-to-End
Bioanalytical Workflow

A streamlined progression from study inception to final archival, ensuring complete data traceability at every phase.

1
Study Design & Setup

Protocol configuration and sample manifest import

2
Sample Receipt & Prep

Barcode tracking, storage mapping, and centrifugation

3
Data Acquisition

LC-MS/MS & ELISA instrument integration and sequence execution

4
Quantification & QA

Automated regression modeling and QA run acceptance review

5
PK Analysis & Reporting

Non-compartmental analysis, SEND export, and final archival

Seamless Integration Ecosystem

Reduce transcription errors with automated data flow across systems.

LC-MS/MS Systems
LC-MS/MS Systems

SCIEX, Waters, Agilent

ELISA Platforms
ELISA Platforms

Automated assay integration

EDC Systems
EDC Systems

Electronic Data Capture

PK Software
PK Software

WinNonlin compatibility

QMS & DMS
QMS & DMS

Zentixs Track Integration

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Key Advantage

Reduce transcription errors with automated data flow across systems.

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Built for Regulatory Excellence

Stay compliant with out-of-the-box regulatory readiness.

21 CFR Part 11 21 CFR Part 11
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21 CFR Part 11 Compliance

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GLP / GCP Guidelines

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FDA & EMA Bioanalytical Validation

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Audit Trail with full traceability

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Electronic Signatures

Security Features Security Features
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Role-based access control

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Secure data storage

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Full audit history tracking

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Data integrity (ALCOA+)

Compliance Simplified Compliance Simplified
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Barcode-based sample labeling

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Storage traceability

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Audit-ready documentation

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Easy inspection readiness

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Frequently Asked Questions

Bioanalytical software helps labs manage study design, sample tracking, instrument data, analysis, QA, and reporting across BA/BE studies.
It tracks sample receipt, storage, movements, processing, and freeze-thaw cycles to maintain a complete chain of custody.
Yes, it supports automated data exchange with LC-MS/MS systems, including SCIEX, Waters, and Agilent platforms.
It supports concentration calculations, regression modeling, PK/TK analysis, and bioavailability calculations within the study workflow.
Reassay and ISR workflows help identify repeat analyses, document decisions, and maintain traceability of incurred sample repeats.
It provides audit trails, controlled workflows, data traceability, and electronic records designed to support 21 CFR Part 11 and GLP/GCP requirements.