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Zentixs Alpha

Bioanalytical Software for BA/BE Studies

Zentixs Alpha is bioanalytical software for BA/BE studies that manages project definition, sample and sequence workflows, LC-MS/MS data, analytical review, result validation, BA dossier compilation, reporting, and electronic archiving in one connected platform.

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

Zentixs Alpha At a Glance

Zentixs Alpha is a bioanalytical software platform for BA/BE laboratories, designed to connect the key stages of the analytical study lifecycle.

From project definition and sample management to LC-MS/MS data handling, analytical review, result validation, BA dossier compilation, reporting, and electronic archiving, Alpha provides a structured digital workflow for managing bioanalytical operations.

Zentixs Alpha bioanalytical software illustration

Bioanalytical Workflow Pathway

A Connected Digital Workflow for Faster, Traceable, and Standardized Bioanalytical Study Execution

Step 01

Define

Set up the project, analytes, time points, CC/QC requirements, samples, templates, and responsibilities.

Core Phase Capabilities & Deliverables
Protocol & blinded study design
Subject cohort & time-point mapping
Regulatory & compliance pre-checks
Project template delegation
Full Audit Trail & 21 CFR Part 11 Compliant Verification
Controlled Workflow

Built for Modern Bioanalytical Study Operations

Designed to support faster execution, stronger data integrity, and better oversight across the bioanalytical study lifecycle.

End-to-End Bioanalytical Software for BA/BE Studies
Integrated BA/BE Study Data Management
Automated Bioanalytical Workflow Management
Centralized Bioanalytical Data & Study Records
Improved Bioanalytical Data Traceability
Reduced Manual Data Handling & Transcription

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

Built Around the Bioanalytical Workflow

Explore how Zentixs Alpha connects project definition, sample management, analytical data, result validation, reporting and electronic archiving.

01

Project & Study Management

Start each bioanalytical project with a structured definition of the analytical requirements.

Zentixs Alpha enables teams to define projects, analytes, time points, CC/QC samples, samples, repeat samples, and project templates. Responsibilities can be delegated within the workflow, helping teams coordinate project execution and review.

Project DefinitionAnalyte MappingCC / QC Setup
01/07
PROJECT STRUCTURE
AnalytesTime PointsCC / QC
Project & Study Management
Sample & Sequence Management
LC-MS/MS Sequence & Instrument Workflow
Bioanalytical Data Management & SDMS
BA Result Compilation & Validation
BA Dossier & Study Reporting
Electronic Records & Archiving

Built for Regulatory Excellence

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

21 CFR Part 11
21 CFR Part 11 Compliance
GLP / GCP Guidelines
FDA & EMA Bioanalytical Validation
Audit Trail with full traceability
Electronic Signatures
Security Features
Role-based access control
Secure data storage
Full audit history tracking
Data integrity (ALCOA+)
Compliance Simplified
Barcode-based sample labeling
Storage traceability
Audit-ready documentation
Easy inspection readiness

Frequently Asked Questions

Zentixs Alpha is a bioanalytical software platform for BA/BE studies that manages project definition, sample and sequence management, LC-MS/MS data workflows, analytical review, result validation, BA dossier compilation, reporting, and electronic archiving.
Bioanalytical software helps laboratories manage analytical study workflows including project setup, sample management, sequence creation, instrument data handling, data review, QC, result compilation, reporting, and electronic archiving.
Yes. Zentixs Alpha is designed for bioanalytical workflows supporting BA/BE studies, covering activities from project definition and sample management through analytical data review, result compilation, reporting, and archiving.
Yes. Zentixs Alpha supports LC-MS/MS sequence and data workflows, including sequence export and instrument-specific data handling for supported Waters, SCIEX, and Thermo LC-MS/MS systems.
Yes. Zentixs Alpha supports sequence creation, sequence requests, sequence approval workflows, 96-plate sequence creation, barcode management, and sequence export.
Yes. Samples can be requested from freezer inventory and routed through a custodian approval or rejection workflow before analytical processing.
Yes. The platform supports auto review, batch acceptance, reviewer review, QC review, annotation, PDF conversion, and summary data extraction.
Yes. Zentixs Alpha supports file selection, BA result compilation, result validation, result QC, result download, and generation of study listings such as CC, QC, and ISR.
Yes. Zentixs Alpha supports BA dossier compilation, final report preparation, supporting study documentation, and submission-related workflows for the applicable sponsor or regulatory authority.
Zentixs Alpha supports archiving of final reports, raw data, electronic records, and supporting study documents as part of the completed BA/BE study record.