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Compliance management: meeting legal and regulatory requirements

octoplant Compliance Management

Complying with auditing and documentation obligations in a legally secure and comprehensive manner

Integrated documentation and (depending on the industry) regulatory-compliant workflows ensure reliable and seamless compliance management that reduces risk. Be assured the production process complies with regulations, is traceable and, in the event of an audit, can be traced.

This is particularly important for industry-specific requirements. For example, it is vital in process engineering production such as chemicals, pharmaceuticals or foodstuffs, but also in critical infrastructures. Compliance features reduce certification compliance risks, which is subject to different strict international rules. This is particularly important when liability issues need to be clarified in the context of production audits, such as who made which changes and when - data transparency in processing is a must.

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CUSTOMER SURVEY

For users of versiondog, the most important reason for using the solution, in addition to the availability of data and documentation, is the increase in transparency and the reduction of manual work.*

*Source: AUVESY GmbH customer survey, survey period 2021, 189 respondents

Features of octoplant Compliance Management

Define approval processes

Set up approval workflow to comply with industry regulation.

Receive GxP documents (GURs)

Support you in documenting your system validation process for global user requirements (GURs).

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Achieve complete control over your production
environment and industrial automation.
Greater data consistency, security, safety, and reliability
with backups and version control.

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What our customers say

Portrait Gilles Gaeng von Thyssenkrupp

The fact that backups can not only be saved, but also compared with each other is an enormous help to us, especially during

audits. The software is set up: all new projects are stored in versiondog* as standard. I see no reason as to why we would ever

do without this system again.

Gilles Gaeng Technical Manager of Maintenance & IT at thyssenkrupp Automotive Systems GmbH
*) versiondog was the former software solution from AUVESY

Support for quality assurance and documentation requirements

When it comes to compliance with technical specifications, laws, and guidelines such as FDA or GxP, various manufacturing production and process documentation is often required. octoplant provides support for quality assurance, production documentation and rule compliance so that evidence can be provided to monitoring authorities and customers.

FAQ

Get answers to the most frequently asked questions about Compliance Management.

 

Can octoplant fulfill IT baseline protection requirements?

octoplant fulfills many of the IT baseline protection requirements for industrial control systems (ICS). octoplant’s key values include prevention, detection, and response in relation to ICS.

Does octoplant support compliance with FDA 21 CFR Part 11 and GMP?

octoplant’s electronic signatures meet the requirements of FDA 21 CFR Part 11 and GMP.

How do approval processes work?

If the GxP customer option is activated, another person must approve or confirm a versioning or check-in process by providing their credentials.

Can changes to an automation project be documented in octoplant?

Yes. Changes to the programs can be documented using comments when performing a comparison. You can document the changes globally or document each adjustment separately.

Case studies