Veolia Water Technologies & Solutions

Sievers DataShare Elite Software: Turn Complex Data into Confident Decisions

One Compliant Database. Múltiples instrumentos. World-Wide Access.

Pharmaceutical manufacturers face a critical challenge: managing data from multiple process monitoring and quality control instruments across sites while maintaining regulatory compliance and data integrity. 

The stakes are high. Whether you're monitoring water quality, validating cleaning processes, or implementing real-time testing (RTT/RTRT) strategies, manual data management from total organic carbon (TOC) analyzers creates problems:

  • Increased compliance risk
  • Slower decision-making
  • Audit vulnerabilities

Sievers DataShare Elite eliminates this complexity. Our digital solution automatically and securely centralizes your TOC and conductivity data from multiple Sievers Instruments - whether they're in the same facility or across the globe - into one audit-ready database.

Descargar folleto DataShare Elite aquí

Is your data management strategy putting you at risk?

Ask yourself:

  • Are you confident your data meets 21 CFR Part 11 and ALCOA++ requirements?
  • Can you access real-time insights from instruments across multiple sites?
  • How much time does your team spend manually collecting and verifying data?
  • Are you audit-ready at a moment's notice?

Sievers DataShare Elite delivers:

  • Regulatory Confidence: Automatic alignment with 21 CFR Part 11 and ALCOA++ data integrity principles
  • Real-Time Intelligence: Monitor, trend, and control data from multiple sites instantly
  • Simplified Compliance: Secure audit trails, electronic signatures, and encrypted data transfer built in
  • Faster Decisions: Transform complex data management into actionable insights

When paired with world-leading Sievers instrumentation - the most accurate TOC analyzers on the market - DataShare Elite seamlessly transfers data into audit-ready intelligence. It's essential for process analytical technology (PAT) applications and real-time testing strategies, reducing risk while driving operational efficiency.

Make complex data management simple. Focus on what matters: producing quality pharmaceutical products with confidence.

Características y beneficios

  • Automated data collection and management

  • Compliance with regulatory requirements (21 CFR Part 11, Annex 11, and ALCOA+ principles)

  • Secure data storage and backup

  • Custom reporting capabilities

  • Multi-instrument connectivity

  • Audit trail functionality

  • Remote data review and electronic sign off

  • Active Directory (AD) capabilities

Especificaciones

Funciones

Pista de auditoría segura:

Revise el registro de auditoría de todos los analizadores conectados y del software DataShare Elite

Figura 2

 

Rendimiento del instrumento de pista:

Compare y haga el seguimiento del rendimiento de cada uno de los instrumentos conectados para detectar rápidamente las desviaciones.

Figura 3

 

Revise y apruebe electrónicamente: revise, comente y apruebe de forma remota los resultados de calibraciones, validaciones, resultados de muestras y más.

Recursos

Preguntas frecuentes

Is Sievers DataShare Elite 21 CFR Part 11 compliant?

 

Yes, the software supports compliance with 21 CFR Part 11 requirements. DataShare Elite was designed to securely and accurately transfer data while complying with 21 CFR Part 11, Annex 11, and ALCOA+ principles.

 

Does DataShare Elite support Active Directory (AD)?

 

Yes, DataShare Elite supports Active Directory (AD).

 

What data can I import from Sievers TOC and Conductivity Analyzers?

 

DataShare Elite software can import data from online results, grab samples, user-created protocols, calibrations, verifications, and validations. The software also imports metadata such as audit trails and errors/warnings from the analyzers to provide a complete history.

 

 

Video: Sievers DataShare Elite Software