Reduce risk and liability 
at your industrial plant 

Manufacturers – especially those in chemical, pharmaceutical, or food and beverage manufacturing – need to meet industry-specific requirements and regulations with their documentation and workflows. 

octoplant version control software’s compliance management features improve traceability in the event of an audit and ensure that your production process complies with regulations.

  • Reduce certification compliance risks, which are subject to strict international rules. 
  • Clarify liability issues in the context of production audits. 
  • Improve data transparency in processing (know who made changes and when). 

octoplant compliance management: 
key features

Define approval processes

Set up a custom approval workflow to comply with industry regulations. 

Receive GxP documents (GURs)

Document your system validation process for global user requirements (GURs). 

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DISCOVER octoplant 
IN DETAIL

Explore all the features of octoplant in the brochure.

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Gilles Gäng Gilles Gäng

The fact that backups can not only be saved, but also compared with each other, is an enormous help for us, especially during audits. The software is set up: all new projects are saved in the AMDT solution by default. 

Gilles Gaeng Technical Manager of Maintenance & IT at thyssenkrupp Automotive Systems GmbH

Support for quality assurance 
and documentation requirements 

Manufacturing production and process documentation is often required in order to comply with technical specifications, laws, and guidelines, such as the FDA or GxP. octoplant offers support for quality assurance, production documentation, and rule compliance, giving you the evidence you need for monitoring authorities and customers.

Screenshot Change history

Get answers to the who, what, when, where and why about your process documentation in a standardized, efficient way. octoplant ensures complete data transparency and traceability by producing audit trail reports at the push of a button – in compliance with applicable IT laws. 

Complete change history for 
supplier management and audits

Get answers to the who, what, when, where and why about your process documentation in a standardized, efficient way. octoplant ensures complete data transparency and traceability by producing audit trail reports at the push of a button – in compliance with applicable IT laws. 

Reporting and 
audit trails 

Access detailed audit-trail reports instantly with octoplant, ensuring robust quality assurance through continuous documentation of program changes.

Screenshot Audit Trail

Access detailed audit-trail reports instantly with octoplant, ensuring robust quality assurance through continuous documentation of program changes.

Screenshot GUR Documentation

octoplant produces standardized documentation, helping you fulfill your documentation requirements. If relevant, octoplant also ensures compliance with the dual control principle. 

octoplant also helps you comply with the ISDS/ISQM standard and can be customized to meet FDA and GxP requirements.

Meet documentation 
and legal requirements 

octoplant produces standardized documentation, helping you fulfill your documentation requirements. If relevant, octoplant also ensures compliance with the dual control principle. 

octoplant also helps you comply with the ISDS/ISQM standard and can be customized to meet FDA and GxP requirements.

CTA Compliance Management

Don’t let outdated technology keep your plant from meeting regulatory standards. Discover how octoplant’s compliance management feature helps you meet industry regulations.

Häufig gestellte Fragen 
zu Compliance Management 

Die Einbindung von Compliance Management verbessert die operative Effizienz von OT-Systemen, reduziert Compliance-relevante Vorfälle und erlaubt einen proaktiven Ansatz in Fragen des Risikomanagements und der Einhaltung behördlicher Vorgaben.

Compliance Management vereinfacht die Dokumentation und die Auditierung durch eine automatische Datenerfassung, durch Audit-Trails und durch umfassende Berichte über Änderungen, Freigaben und Compliance-Aktivitäten.

Compliance-Verstöße in OT-Umgebungen können behördliche Sanktionen, Betriebsunterbrechungen, einen Vertrauensverlust auf Kundenseite und Haftungspflichten zur Folge haben. 

octoplant unterstützt eine Reihe von Compliance-Standards, darunter die FDA-Richtlinie 21 CFR Part 11 und die Good Manufacturing Practices (GMP). Zudem bietet octoplant Hilfe bei der Einhaltung der ISDS/ISQM-Norm und erlaubt den Zuschnitt auf spezielle regulatorische Anforderungen an Produktion und Qualitätssicherung.

octoplant vereinfacht standardisierte Dokumentationsprozesse und hilft bei der Einhaltung gesetzlicher Verpflichtungen, bei Bedarf unter Einhaltung des Vieraugenprinzips. Umfassende Audit-Trails und ein individualisierbares Reporting sind Teil des Pakets.

Viele Anforderungen des IT-Grundschutzes für Industrial Control Systems (ICS) können mit octoplant erfüllt werden. Insbesondere Prävention, Detektion sowie Reaktion in Bezug auf ICS sind Key Values von octoplant.

Ja. Mit Hilfe der Kommentarfunktionen beim Vergleich lassen sich Änderungen an den Programmen dokumentieren. Hierbei besteht die Möglichkeit, die Änderungen global oder jede einzelne Anpassung separat zu dokumentieren.

Ist die Option für GxP-Kunden aktiviert, so ist es – während eines Versionierungs- oder Check-in-Prozesses – notwendig, dass eine weitere autorisierte Person diesen Prozess vor der Implementierung mit ihren Credentials freigibt bzw. bestätigt.

Resources

CERN  LHC CERN  LHC
Case Study

On the trail of the Big Bang at CERN

CERN uses AMDT's data management system to safeguard and monitor about 500 industrial controllers in the Large Hadron Collider (LHC), the world's largest particle accelerator.

Read the case study
Siemens Energy Siemens Energy
Whitepaper

AUDITS IN AUTOMATED PRODUCTION

Master process audits with ease! Read our white paper to get answers on how to prepare for and perform audits in automated manufacturing. 

Download white paper

GET A 360-DEGREE VIEW 
OF YOUR PRODUCTION ENVIRONMENT

IoT Device Management

Know and manage what is going on with your devices.

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Safeguarding Assets

Ensure all devices are configured correctly.

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Instant 
Recovery

Quickly bring back the right system configurations.

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Business Intelligence

Make more informed decisions.

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Operational Efficiency

Drive efficient operations.

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Compliance Management

Fulfill regulatory requirements and streamline production audits.

Threat 
Protection

Take proactive measures to prevent security breaches.

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Education & Training

Use octoplant effectively.

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