Smart image database with GxP option
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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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.
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.