Initial Certification: 01/2022
MGI ZTRON Appliance is an integration of instruments related to gene sequencing, as a control center, data center and quality management center to record and supervise the daily work of the laboratory. It is a combination of hardware and software. In the entire process chain of gene analysis (from sample collection, sequencing, analysis to delivery of results), ZTRON represents only the part of analysis and delivery. In this context, it takes care of the entire process management, monitoring, and work trace tracking record from sample receiving, task distribution, sample testing, data review to report issuance. Latvia MGI Tech, SIA facilitates the data protection compliant use of MGI ZTRON Applicance by providing comprehensive, meaningful, intelligible and up-to-date information to the users of the ToE.
Product/Version
MGI ZTRON Appliance
Version 1.2.0
Qualification: IT product
View the MGI ZTRON Applicance certificate
Cert. No.
EP-P-QA3AZK
Version of Certification Criteria
Gültigkeit
28/01/2022 – 31/01/2024
Kurzgutachten
MGI ZTRON Applicance Short Public Report 01/2022 
Manufacturer/Provider
Latvia MGI Tech, SIA
Mārupes nov.
Mārupes pag.
“Lidostas parks”
LV-2167
BEST
Comprehensive, intelligible and up-to-date documentation is in place which informs the users of MGI ZTRON Appliance about their responsibilities as controllers when it comes to the processing of personal data.
ATTENTION
MGI ZTRON Appliance facilitates its privacy compliant use. However, it is the users’ responsibility as controllers to stick to the guidane provided by Latvia MGI Tech and to use the ToE in a way that complies with all relevant provisions of the GDPR.
SUMMARY
MGI ZTRON Applicance is an integration of instruments related to gene sequencing, as a control center, data center and quality management center to record and supervise the daily work of the laboratory. It is a combination of hardware and software. In the entire process chain of gene analysis (from sample collection, sequencing, analysis to delivery of results), the ToE represents only the part of analysis and delivery. In this context, the ToE takes care of the entire process management, monitoring, work trace tracking record from sample receiving, task distribution, sample testing, data review to report issuance. Data is stored within the filesystem and the database.
There are three interfaces to external systems:
1. The connection to a sequencer, where all needed data is generated. Data is imported via files.
2. A user interface, which allows to download results of the analysis and to process the results for further purposes.
3. The “App-Shop”, where new applications (extensions) or updates for the ZLIMS (MGI’s laboratory information management system) could be bought. The “App-Shop” as such does not form part of the ToE (cf. also below at details).
DETAILS
Initial Cert 2022/02
The ToE includes:
– The Hardware, containing the computing nodes, the storage nodes, the management node, the switch;
– The Software, containing the ZLIMS with the applications (Laboratory, Analysis, Data, Samples, Setting);
– The ZTRON is set up via Local Area Network Connection (LAN) and operated without any connection to the internet.
The ToE does not include:
– Components needing internet connection, especially the integrated “App-Shop” and any additional applications (which can be installed using the “App-Shop”);
– The payment process since this process precedes the use of the product and is self-contained;
– The maintenance process and any related data processing operations.
Beyond the ZLIMS, the ToE does not include the operation system (CentOS) with all its features.
Legal Evaluator
Dr. Jan Peter Ohrtmann (Rechtsanwalt)
PricewaterhouseCoopers Legal AG
Moskauer Str. 19
40227 Düsseldorf
Deutschland
Technical Evaluator
Andreas Bethke
B³ | Informationstechnologie
Papenbergallee 34
25548 Kellinghusen
Deutschland