Uncompromising Optical Precision & Reliability

ZEISS systems deliver unmatched image quality, reproducibility, and robustness. All essential for researchand quality control under strict GxP regulations.

Comprehensive GxP Compliance

ZEISS supports the entire compliance lifecycle: from IQ/OQ/PQ documentation, 21 CFR Part 11–ready software with secure audit trails and

Seamless Hardware–Software Integration

High-end ZEISS microscopy hardware is combined with validated software for acquisition, analysis, and data management. The result: streamlined workflows that meet regulatory standards withoutcompromising productivity.

AI-Driven Automation & Digitalization

Intelligent automation and AI-powered analytics reduce human error, standardize processes, andaccelerate workflows – boosting efficiency both in discovery and pharmaceutical QC environments.

Flexible & Scalable Solutions

From global pharma organizations to specialized biotech labs, ZEISS offers modular and customizablesolutions tailored to your processes, sample types, and regulatory requirements.

Proven Industry Trust

For decades, leading pharmaceutical and biotech companies worldwide have relied on ZEISS as a trusted partner in regulated environments. This proven track record ensures sustainable, future-ready investments.

ZEISS GxP Toolkit

for regulatory compliance and operational excellence

Your turnkey platform for compliance-ready microscopy

Empowering your lab to meet the highest regulatory standards

GxP (Good x Practice) refers to a set of guidelines and regulations designed to ensure that products are consistently produced and controlled according to quality standards. These practices are particularly critical in industries like pharmaceuticals, biotechnology, and medical devices, where compliance with regulations ensures safety, efficacy, and data integrity. GxP encompasses various subsets, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), each addressing different stages of product development and production. Adhering to GxP ensures that processes are repeatable, traceable, and accountable, helping companies meet rigorous regulatory requirements while maintaining high-quality standards.

From basic hardware qualification to advanced solution qualification

ZEISS offers cutting-edge microscopy solutions and services tailored to meet the stringent regulatory requirements of pharmaceutical, biotech, clinical and routine applications. Our GxP-compliant systems are designed to provide unparalleled imaging precision while ensuring compliance with key international standards such as FDA 21 CFR Part 11, EU Annex 11, GMP, GLP, GCP and NMPA as well as industrial standards such as ISPE GAMP 5.

Compliant digital and automated microscopy

ZEISS ZEN core imaging software with GxP Toolkit transforms your microscopy platform into a fully validated, regulatory-compliant digital solution. Designed for use in regulated GxP environments, ZEISS delivers more than just compliant software and qualified hardware.

What truly differentiates the solution is the end-to-end service provided by dedicated ZEISS GxP specialists, who guide customers through every regulatory and validation hurdle. From initial risk assessment and validation planning to documentation, installation, qualification, and ongoing compliance support, ZEISS ensures a smooth, audit-ready implementation.

Centralized Data Management: Store all relevant data in one place and allow authorized users on role-based access and definable user management
Audit Trail Tool for complete tracking of all changes and electronic signatures to ensure data integrity
Compliance with CFR21 Part 11 and EU Annex 11 standards User management
Commercial Off-The-Shelf (COTS) standard software, adaptable to specific requirements through configuration or parameterization, aligning with GAMP 5 Categories 3 and 4

Customizable GxP workflows

ZEISS GxP solutions enable you to create flexible, compliant workflows for various applications such as:

Particle Analysis: Ensure compliance with Ph. Eur. 2.9.19 and USP <788>
Sterility & Contamination Testing: Detect microbial contamination in pharmaceuticals
Cell Culture Monitoring: Track morphology, viability, and growth dynamics
Material Verification: Validate crystallinity, purity, and structure consistency
Quality Insurance: e.g. Osmotic-controlled release oral delivery system (OROS)
Screening of targets or drugs

Fast-track compliance with ZEISS Qualification Services

We provide full Installation Qualification (IQ) including system calibration and Operational Qualification (OQ) with expert consulting, ensuring that your system is ready for audit at any time, regardless of you work with ZEISS Primostar 3 or ZEISS Celldiscoverer 7.

ZEN Data Storage: Scalable and secure

Centralized, GxP-compliant storage ensures data integrity with:

Secure, auditable archives
Web and mobile access through ZEN Data Explorer
Disaster recovery and backup features

Pharmaceutical quality control

Particulate matter analysis: Ensure compliance with USP <788> and Ph.Eur. 2.9.19
Raw material inspection: Analyze crystallinity, polymorphism, and other characteristics
API integrity verification: Assess uniformity and quality of active pharmaceutical ingredients (APIs)

Biotech & cell culture monitoring

Morphology tracking: Automatecell morphology assessments
Growth curve analysis: Monitor cell viability and growth dynamics
Multiwell plate imaging: Streamline high-throughput imaging processes

Sterility & environmental monitoring

Microbial detection: Monitor for bacteria, fungi or particulatecontamination
Controlled workflows: Ensure compliance with sterility and environmental monitoring standards

Talk to our specialists about your GxP requirements

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Why ZEISS GxP solutions

ZEISS systems deliver unmatched image quality, reproducibility, and robustness. All essential for research and quality control under strict GxP regulations.
ZEISS supports the entire compliance lifecycle: from IQ/OQ/PQ documentation, 21 CFR Part 11–ready software with secure audit trails and user management, to periodic re-qualification services. Your systems are always audit-ready.
High-end ZEISS microscopy hardware is combined with validated software for acquisition, analysis, and data management. The result: streamlined workflows that meet regulatory standards without compromising productivity.
Intelligent automation and AI-powered analytics reduce human error, standardize processes, and accelerate workflows – boosting efficiency both in discovery and pharmaceutical QC environments.
From global pharma organizations to specialized biotech labs, ZEISS offers modular and customizable solutions tailored to your processes, sample types, and regulatory requirements.
For decades, leading pharmaceutical and biotech companies worldwide have relied on ZEISS as a trusted partner in regulated environments. This proven track record ensures sustainable, future ready investments.

Lets talk about your GxP projects

Reach out to our experts

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Downloads

Accelerate Your Qualification Process

ZEISS IQ/OQ Service

394 KB

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GxP Module in ZEISS ZEN core

Your Software Module for Regulated Industries.

648 KB

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Application of GxP principles to routine metallography

ZEISS ZEN core Module GxP for auditability and data integrity in the metals industries

5 MB

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Automated Microscopic Particle Measurement in the Pharmaceutical Industry

5 MB

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ZEISS GxP Toolkit

Empowering your lab to meet the highest regulatory standards

From basic hardware qualification to advanced solution qualification