Download free white papers now
Get your maintenance processes ready for the future and find out comprehensive information on version and data management, how they differ from each other or how it can help during the different phases of an audit in automated production. Here, you will find an overview of our free downloads
... by monitoring intelligently
This free white paper is for plant managers facing the challenges of digital production processes.
the “Firefighting” Mentality in Automation
This free white paper discusses how better data management can transform industrial automation for increased productivity with fewer problems.
...fulfill them with help from versiondog
This free guide is aimed at all KRITIS companies dealing with the measures recommended in the IT baseline protection for KRITIS operators.
...of version control & backup
This free white paper takes a look at the most common myths and misconceptions surrounding this field. At what point does the use of version control systems that are specifically adapted for automated production start to make sense?
And what are some of the things to watch out for when it comes to choosing the right one?
...in industrial automation
This free white paper explains the best way to approach such an audit, what exactly is involved, and what are some of the potential pitfalls?
How does a data management system help to answer the typical questions arising from process documentation (who, what, where, when and why), and how does this provide a reliable foundation for audit trails?
...for FDA 21CFR11
FDA regulations have specific rules around electronic signatures. Some regulations address secure program access, audit trails and version control. A Change Management System contains tools that can significantly streamline the process of making changes in a validated environment and help to ensure that proper change processes are followed.
...with change management
Automation devices and their logic programs are vital to the plant and proper safeguards are needed to protect and manage change in these assets. Find out how to safeguard your plant from errors and downtime.
...an Industrial Cyber Attack
Cyber risks are on the rise. Industrial operations must consider not if a cyber attack will occur, but how to respond when it does. This white paper provides the answer.
This whitepaper provides information on how automation change management features align with requirements set forth by the FDA. More specifically, it contains guidance related to FDA regulation 21 CFR Part 11 for organizations considering AUVESY-MDT software solutions. The intent is to establish a mutual understanding of the rules set forth in Part 11 and explain how AUVESY-MDT can help our customers comply with the rules.
Programmable Logic Controllers (PLCs) are the backbone of automated manufacturing in the pharmaceutical, biotechnology, and medical device industry. These devices are programmable and rely on digital programs that define their functionality and operation. The programs are stored electronically in the device and on backup electronic media. For this reason they are considered electronic records and fall under the requirements imposed by 21 CFR Part 11. Methods for conventional office records tracking and change control would not be sufficient for records associated with programmable devices. AutoSave is part of the change control and audit infrastructure that ensures regulatory compliance.