Sievers DataShare Elite Software: Turn Complex Data into Confident Decisions

One Compliant Database. Instruments multiples. 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.

Téléchargez la brochure DataShare Elite ici

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.

Fonctionnalités et avantages
Caractéristiques
Ressources
FAQ

Fonctionnalités et avantages

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

Caractéristiques

Piste d’audit sécurisée :

Vérification de la piste d’audit pour tous les analyseurs connectés et le logiciel DataShare Elite

Performances de l’instrument de suivi :

Comparer et suivre les performances de chaque instrument connecté pour identifier rapidement des excursions.

Révision et approbation électroniques : examinez, commentez et approuvez à distance les résultats des étalonnages, des validations, des résultats d’échantillons, etc.

Ressources

FAQ

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.