Smart image database with GxP option

Smart image database with GxP option

ZEISS ZEN Data Storage

ZEISS ZEN Data Storage is an SQL server-based database solution for all images, image analyses and reports created with and in ZEISS ZEN core. Benefit from the following advantages with the ZEISS ZEN Data Storage image database software for your company:

  • Cost-effective database solution for your technical images, analyses and reports

  • High data security thanks to SQL-based server structure

  • Cross-site data exchange (images, jobs, reports, methods, AI models) and option of web-based, mobile access to the data

  • User management system: can be used with any number of clients at no additional cost

  • Easy traceability of results and analyses with GxP option and audit trail tool

  • Simple and secure data access management

Keep the overview with the ZEISS ZEN Data Storage image database

With the ZEISS ZEN Data Storage image database, you can save and archive your images, image analyses and reports. This means: All data is stored in a central location. They can thus be viewed by approved users and changed if necessary. Access rights can be defined individually, e.g. read-only rights or the right to make changes. ZEN Data Storage allows both expert and novice users to easily share images, instrument presets, workflows, analysis data, reports and other file formats. Common file formats can be integrated into the desired folder structure at any time.

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Five steps to a connected result

Five steps to a connected result
Step 1: Data acquisition

Acquisition of images from different microscopy systems.

Step 2: Analyze & Evaluate

Acquisition of images from different microscopy systems.

Step 3: Saving data with ZEISS ZEN Data Storage

For centralized access to images, analysis data, presets, workflows and reports.

Step 4: Mobile access

Mobile access and data capture on all mobile devices such as tablets, notebooks and smartphones are possible.

Step 5: Networking & Sharing

Data and workflow exchange between systems, laboratories and locations.

Who is ZEISS ZEN Data Storage suitable for?

ZEISS ZEN Data Storage is suitable as an image database for any company in which analysis and report data from imaging systems must be stored in one place over a defined period of time. Files can be shared locally, e.g. within the laboratory or across companies, but also globally - via a single storage location.

The smart image database enables a new level of collaboration by managing image files and associated analyses centrally. Our solution enables you to define an evaluation and reporting standard and make it available to all responsible persons and organizational units. We would be happy to explain our solution to you in an expert discussion.

How can workflows and AI models be shared with the organization?

With smart access management, the ZEISS ZEN Data Storage image database releases and transmits not only data but also methods, templates and AI models to defined organizational units and persons. Users with access to the image database can view the data at any time and use it for their analyses and reports.

ZEN Data Storage with GxP option and audit trail tool

The special feature: ZEN Data Storage with GxP option and audit trail tool

GxP option

The abbreviation "GxP" stands for "Good x Practices" and refers to a group of quality standards. GxP is used in many industries, e.g. in the medical and manufacturing sectors. The exact requirements may vary depending on the area of application, but in general they are intended to ensure that products or services are consistent and reliable and comply with legal requirements.

ZEISS ZEN Data Storage fulfills defined and validated requirements for data security, traceability and documentation. This ensures that the data is managed in accordance with the relevant GxP regulations. This is how ZEISS supports you with IQ/OQ.

Definition of IQ - Installation Qualification

During IQ (Installation Qualification), it is checked and documented whether the previously defined requirements have been met when setting up and installing a system. OQ (Operational Qualification) is a check of the correct functioning of individual components of a system or device. The form in which this review is carried out and the criteria that apply are also determined in advance and must also be approved.

Audit Trail Tool

Audit trail in ZEN core with activity log

Audit Trail Tool

The audit trail tool or audit log seamlessly records changes made in the ZEISS ZEN core software and all software processes. This makes every action performed in ZEISS ZEN Data Storage traceable. The use of an audit trail is particularly important in areas such as FDA certification, data security and quality assurance. Unauthorized access to confidential information and data loss can thus be detected quickly and, in the best case, prevented. An audit trail tool also makes it easy to keep track of changes and older file versions.

A typical example of an audit trail is a record of all changes to a file, including the time of the change, the user name, the type of change and the previous and new content. The audit trail tool of the ZEISS ZEN core software can also contain information about access to a system, e.g. when users logged in, what actions were performed and when they logged out.

GxP in everyday working life

With the new GxP module including audit trail, all work steps within the software can be traced seamlessly. With the help of the tool from the ZEISS ZEN core environment, workflows to be carried out can be defined and documented in the image database software.

One example: A validated pharmaceutical company, FDA-certified (21 CFR Part 11 compliance), must implement proper batch documentation in its own processes. This means that subsequent intervention and modification options must not be possible. When using ZEISS ZEN core in an automated coating thickness measurement of pills, the result must not be changeable at the end of the analysis process. It must then be stored securely in the ZEN Data Storage image database environment. In order to protect the data from later manipulation, its storage always includes the digital signature of the person responsible. If a change is made, it is recorded by the audit trail tool. Any incorrect result or any deviation from the specified work steps is recognized by the system. This makes it possible to check the validity of all data and signatures at any time.

Try out ZEN core

Simply register and test ZEN core free of charge - without any contractual obligation. Get to know our image analysis and machine learning tools in up to 60 days.

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