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.
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
Set up approval workflow to comply with industry regulation.
Support you in documenting your system validation process for global user requirements (GURs).
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.
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.
octoplant’s electronic signatures meet the requirements of FDA 21 CFR Part 11 and GMP.
If the GxP customer option is activated, another person must approve or confirm a versioning or check-in process by providing their credentials.
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.
The Smart car may be small in size – however, as far as the reliability of its production processes is concerned, the city vehicle encompasses just as many demands as do larger vehicles. thyssenkrupp produces Smart vehicles at its Hambach (Moselle) factory, the maintenance department of which employs AUVESY's versiondog.
Backing up and monitoring of Industrial control system programs for the Large Hadron Collider (LHC) at CERN near Genevahas been entrusted to the data management system versiondog. The European Organization for Nuclear Research uses the system to manage the data of around 500 components, making versiondog one of CERN's standard technologies.