Standard 21 CFR Part 11 and CMMS: our white paper is available!

The Mobility Work team invites you to discover its latest white paper on the 21 CFR Part 11 Standard! The objective of this support is to present the standard and to demonstrate the importance of a good CMMS in this project. Indeed, new generation maintenance management tools such as Mobility Work have the capacity to support companies in the sectors concerned (agri-food, pharmaceutical and cosmetic industries, etc.) in this process, which is sometimes complex, and to help them meet the requirements of this standard.

What is 21 CFR part 11?

Standards are becoming increasingly important in the global economy and industry and are applicable at all levels of production, including maintenance. It is therefore quite natural that Mobility Work is committed to presenting the challenges and explaining why it is becoming essential for many companies.

In 1997, the FDA, the American Food and Drug Administration, has added the chapter “Part 11 - Electronic records; Electronic signatures” to the CFR (Code of Federal Regulations). The aim of this new standard was to avoid any attempt to falsify documents and data.

The white paper is available for download from the Mobility Work website, or by clicking on the button below.

DOWNLOAD THE WHITE PAPER

Its challenges

Meet the compliance criteria of the 21 CFR Part 11 Standard has therefore become an imperative for all companies from different sectors (agri-food, pharmaceutical and cosmetic industries, etc.) who wish to enter the American market. It is also an opportunity for them to improve their processes, especially in terms of maintenance, and to limit the number of production incidents, including those due to computer security or health problems. Compliance and compliance with this standard then makes it possible to gain in productivity.

Adopting a CMMS to comply with the 21 CFR Part 11 standard: an essential step

So it is here that the GMAO Come into play: the maintenance management tools have advanced functions thanks to which it is possible to manage electronic signatures, in particular through various levels of approval and to have access to the recording of all maintenance actions carried out. In addition, all intervention reports, machine modifications and revisions are searchable and traceable.

In addition to the presentation of the 21 CFR Part 11 Standard, this white paper brings together a set of information on the sectors concerned, compliance criteria, tools for complying with the standard, audit trails and the general regulation on data protection and security. The importance of a Next generation CMMS It is also highlighted, as an efficient and scalable maintenance management tool is one of the keys to complying with the standard.

Mobility Work CMMS to meet the requirements of the standard

Mobility Work can be the ally of each company in this project, since our application is adapted to the challenges ofthe 21 CFR Part 11 Standard. Establishing this standard may seem restrictive, but with the right tools and the right support, it is possible to see it as an opportunity to look to the future and make its factories more reliable and more productive.

Reading the Mobility Work White Paper allows you to learn more about the challenges of n21 CFR Part 11, on the importance of a good maintenance management tool and this also makes it possible to anticipate and analyze the consequences and benefits that this advance will have on your business. This also marks the first step towards a global approach to continuous improvement of the quality of its products and services, thanks to the principles and tools of Industry 4.0.