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Welcome to Sartorius Software Solutions

Lab Connectivity & Data Integrity

Modern laboratories face challenges with inefficiencies in data management and compliance. Manual processes often lead to errors and delays, putting data integrity at risk. Ensuring GxP compliance and data security, while overcoming productivity bottlenecks and decision-making obstacles, is essential to improving lab efficiency and accuracy. 

Enhance your lab's efficiency and accuracy with Sartorius' comprehensive lab software solutions. Our digitalization tools enable paperless workflows and seamless connectivity across your lab. 

Tailored for QC Lab Managers and Lab Automation Specialists, these solutions deliver reliable test results, validated data systems, and robust data integrity. With built-in compliance for GxP regulations, our software safeguards against unauthorized access and data manipulation, ensuring accuracy and consistency. 

Boost productivity, streamline data handling, and make confident decisions with Sartorius' advanced lab solutions.

Featured Resources

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Webinar

You're Now Connected: Prepare Your Lab for the Future

This webinar will explore the crucial roles of data integrity and laboratory connectivity in the lab.

Blog

Data Integrity Takes Center Stage in Lab Quality Control

Staying compliant helps labs avoid setbacks from regulatory scrutiny while protecting the safety and reliability of their products.

Discover Lab Software Solutions and Digitalization Tools

Ingenix® Suite: Streamline Pipette Calibration and Balance Workflows

The Sartorius Ingenix® Suite transforms lab workflows by streamlining weighing processes, external balance calibration, and pipette checks with an intuitive interface. It enhances data security and integrity, fully supporting 21 CFR Part 11 and EU Annex 11 compliance. The Pipette Calibration module aligns with ISO 8655:2022 and ISO/IEC 17025 standards, ensuring global compliance. Ingenix® Suite offers flexible data management, functioning independently or integrating with LIMS and ELNs, while connecting seamlessly with any pipette, Sartorius balances, and selected third-party balances.

Explore Ingenix® Suite

Enhance Lab Efficiency with Cubis® II Balances

Laboratory balances are critical for precise experimental results. The Cubis® II by Sartorius offers a premium balance portfolio that seamlessly integrates into modern lab environments while meeting regulatory connectivity standards. Its features include Ethernet/Wi-Fi connectivity, intelligent error prevention, comprehensive audit trails, and customizable QApps for diverse weighing methods. Designed for data integrity, regulatory compliance, and workflow efficiency, the Cubis® II is the ideal choice for labs prioritizing high performance and reliability.

Explore Balance Connectivity

Picus® 2 Electronic Pipettes: Connectivity & Efficiency

Picus® 2 electronic pipettes, equipped with Bluetooth connectivity, integrate seamlessly with the Sartorius Pipetting mobile app and other systems to enhance sample preparation and pipette management. The app offers guided workflows, updates, and direct transfer of pipetting steps, ensuring accuracy and efficiency. With customizable workflows and detailed logs, it supports traceability and reproducibility, making it an indispensable tool for laboratory professionals.

Explore Picus® 2

an Octet®️ R8 system in a GxP environment, illustrating compliance with FDA CFR Part 11 for the Octet®️ BLI platform.

Octet® CFR Software: Connectivity & Compliance

Octet® biolayer interferometry (BLI) supports a range of applications, including quantitation, potency assays, impurities testing, and ligand binding assays, offering versatile solutions for diverse laboratory needs. The Octet® CFR Software ensures seamless connectivity and compliance with 21 CFR Part 11 for GLP and GMP laboratories. It provides secure electronic records, user access control, and detailed audit trails, enhancing data integrity and regulatory compliance while streamlining validation and documentation processes.

Explore GxP Compliance Tools

iQue® 21 CFR Part 11: Cell Analysis & Viability

Whether in development, QC, or manufacturing, the iQue® 21 CFR Part 11 software module simplifies traceable electronic record-keeping in your flow cytometry workflow.

Key features include global audit event tracking, user security, and electronic signatures with standardized responses for organizational consistency. Paired with iQue Forecyt® Software and the iQue® High-Throughput Screening (HTS) Cytometry Platform, it enables secure, compliant, and efficient data management.

Explore iQue® 21 CFR Part 11 Software

Sterisart® Pump: Sterility Testing for a Connected Era

The Sterisart® Universal | Gen 4 pump is optimized for seamless integration into barrier technology environments, ensuring precise, contamination-free sample transfers during sterility testing. With advanced connectivity options such as USB, Ethernet, and REST API, it integrates effortlessly with existing systems. Fully compliant with 21 CFR Part 11, the pump offers secure electronic documentation, customizable user access controls, and detailed audit trails, enhancing data integrity and regulatory compliance in connected, modern labs.

Explore Sterisart® Pump

Incucyte® 21 CFR Part 11 Software Module

Incucyte® software simplifies acquiring, viewing, analyzing, and sharing live-cell images. The Incucyte® 21 CFR Part 11 Software Module adds comprehensive security and electronic record-keeping capabilities. Configure system access with user permissions and exclusive roles, trace protocol deviations from creation to execution, and customize authentication actions to meet your lab's exact requirements. Support compliance needs while transforming images into actionable insights.

Explore Incucyte® 21 CFR Part 11 Software Module

Resources for Data Integrity and Compliance

Blog

Why the FDA Encourages Continuous Manufacturing Supported by Data Mode...

The FDA and other regulatory agencies encourage pharma and biopharma companies to adopt continuous manufacturing using data models because it improves...

Scientist using Ingenix Suite software for lab data and fleet management.
Infographic

Ensuring Data Integrity: Connected Solutions

Explore this infographic to understand the importance of data integrity, the FDA’s focus on data integrity violations.

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Infographic

Data Integrity in Pharmaceutical Quality Control

This infographic provides an overview of key terms and definitions, points of compliance, and ways to achieve quality control and data integrity.

Webinar

Importance of Data Integrity in Microbiology Labs

Marie Dorna discusses the importance of data integrity in microbiology labs.

Sterisart Universal Pump Reporting CFR Part 11 Compliance - shown on laptop screen
Video

Sterisart®️ Universal Pump | Gen 4 - 21 CFR Part 11 Compliance

Visual Guide for a 21 CFR Part 11 Sterility Testing Workflow

Article

Assuring Accuracy, Preventing Fraud

The Critical Role of Validation in Bioanalytical Methods

21 CFR Part 11 Compliance Checklists

Brochure

21 CFR Part 11 Compliance Support Technical Specifications

iQue® Audit Trail, Electronic Records and Electronic Signature Features to Support 21 CFR Part 11 Workflows

Article

Protecting Data Integrity

Download this resource to learn more about why they should be and which instrument features enable compliance.

Octet®️ BLI 21 CFR Part 11 Compliance Checklist eBook
eBook

GxP Compliance Without the Complexity

A comprehensive tool set for compliance makes the Octet® BLI platform an ideal analytical instrument in regulated environments.

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White Paper

Sterisart® Universal Pump | Gen 4

Discover how the Sterisart® Universal | Gen 4 ensures your pharmaceutical processes meet the stringent requirements of 21 CFR Part 11.

21 CFR Part 11 compliance flyer
Flyer

Incucyte® 21 CFR Part 11 Software Module

Understand the features of the Incucyte® 21 CFR Part 11 compliant software.

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