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GxP SUITE

21 CFR part 11 compliant imaging toolbox

The 21 CFR part 11 / EU GMP Annex 11 regulations establish criteria for electronic records and electronic signatures to be trustworthy and reliable. 

The goal is to minimize the chances of data falsification and maximize the chances of detecting falsification. 

To achieve this, we have created the GxP SUITE for your imaging projects - all specifically designed for SYNENTECs imaging and automation solutions.

Discover all the advantages

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Performs...

  • 21 CFR part 11 compliant high-throughput cell imaging
  • protection of primary data (metadata & image raw data)
  • protection of derived data (processing and results)
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Supports...

  • data security
  • user authentication using advanced digital fingerprint technology 
  • login controls
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Offers...

  • audit trailing with pdf-report for experiments or templates of the audit trail
  • versioning
  • electronic signatur

plug and play solution

3 Säulen des AUDITs

GxP SUITE

Our three mainstays of 21 CFR part 11 compliance

User Management

  • Group items
  • Security management by customer‘s IT
  • YTUser / YTManager / YTAuditor
  • Certification by training

Data Integrity

  • Local database
  • Digital fingerprinting technology
  • Traceable validated experiment format
  • Data integrity check

Audit Trail

  • Full traceability
  • Multiple entries searchable and filterable
  • Exportable to pdf

Data integrity made simple

Workflow of advanced safety features

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21 CFR part 11 compliant imaging and data handling

Validated automation set-up

This automation scheme shows SYBOT-1000 automation with CELLAVISTA 4K High End and Cytomat 2-C LiN. All processes including the Batch Processing are audited completely and result in a 21 CFR part 11 compliant imaging processes. Using AUDIT Server enables fully flexible usage of the  imaging systems even providing a continuous audit trail even when an experiment is imaged on different imagers at different points in time. This feature can also be applied to third party automation workcells involving multiple imaging systems.

1) YT-AUDIT : 21 CFR part 11 plug-In for YT-SOFTWARE. 2) AUDIT-TRAIL: Audit tool (local) to check integrity of the experiment(s) & 21 CFR part 11 compliance. 3) AUDIT scheduler: 21 CFR part 11 Plug in for SYNET.Scheduler. 4) AUDIT SERVER: Audit tool (Network) to check integrity of the experiment(s) & 21 CFR part 11 compliance.
1) YT-AUDIT : 21 CFR part 11 plug-In for YT-SOFTWARE. 2) AUDIT-TRAIL: Audit tool (local) to check integrity of the experiment(s) & 21 CFR part 11 compliance. 3) AUDIT scheduler: 21 CFR part 11 Plug in for SYNET.Scheduler. 4) AUDIT SERVER: Audit tool (Network) to check integrity of the experiment(s) & 21 CFR part 11 compliance.

Data integrity made simple

Validated environment from a single source

Download Brochure

SYNENTECs GxP SUITE uses advanced digital fingerprint technology and audit trailing in a highly automated manner for maximum 21 CFR part 11 compliant high-throughput cell imaging - all specifically designed for SYNENTECs imaging and automation solutions.

YT-AUDIT uses advanced digital fingerprint technology and audit trailing in a highly automated manner for maximum 21 CFR part 11 / Annex11 compliant high-throughput cell imaging.