GxP Compliance

Transforming Processes in in Regulated Environments

Compliance for Microscopic Processes

The pharmaceutical or medical device industry holds challenging topics such as GMP or GLP, FDA 21 CFR Part 11 or Pharmacopoeia as well as GxP and the validation of customer processes to make them GMP compliant.  

As digitalization is increasing, audits become more stringent and you have to meet complex regulatory standards  according to GMP or GLP.

To meet the requirements it is important to make your system compliant the regulations and validate processes.

GMP Compliance for Biotechnology and Pharmaceuticals

How can the complexity be managed?

GxP Compliance

Our Solution

Completing the qualification processes can be eased with the ZEISS GxP Toolkit in ZEISS ZEN core. Make them GMP-compliant  with reliable microscopic process control.  

ZEN core with it’s GxP functionality allows you to customize, perform, and document your microscopy examinations in compliance with regulations such as FDA 21 CFR Part 11 or Pharmacopoeia.

ZEISS has already successfully supported over 100 GxP projects and is ready to support more.Configurable user management

  • Guided workflows
  • Digital Signatures
  • Complete audit trail
  • Checksum protection of data

Profit from a variety of tools and functionalities and combine required qualification and validation activities.

GxP Toolkit in ZEISS ZEN core

Your FDA 21 CFR Part 11 Ready Software Module for Regulated Industries

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