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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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.

Frequently asked questions
Compliance Management 

The integration of compliance management improves the operational efficiency of OT systems, reduces compliance-related incidents, and enables a proactive approach to risk management and regulatory compliance.

Compliance Management simplifies documentation and auditing through automatic data collection, audit trails, and comprehensive reports on changes, approvals, and compliance activities.

Compliance violations in OT environments can result in regulatory sanctions, business interruptions, loss of customer trust, and liability obligations. 

octoplant supports a range of compliance standards, including FDA guideline 21 CFR Part 11 and Good Manufacturing Practices (GMP). In addition, octoplant offers assistance with compliance with the ISDS/ISQM standard and allows customization to specific regulatory requirements for production and quality assurance.

octoplant simplifies standardized documentation processes and assists with compliance with legal obligations, adhering to the dual control principle where necessary. Comprehensive audit trails and customizable reporting are included in the package.

Many of the IT baseline protection requirements for industrial control systems (ICS) can be met with octoplant. Prevention, detection, and response in relation to ICS are key values of octoplant.

Yes. The comment functions in the comparison tool can be used to document changes to the programs. It is possible to document the changes globally or to document each individual adjustment separately.

If the option is activated for GxP customers, it is necessary during a versioning or check-in process for another authorized person to approve or confirm this process with their credentials before implementation.

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

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

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