Standard 21 CFR Part 11: how to meet it using CMMS?

La Standard 21 CFR Part 11 is mandatory for all businesses that sell products in the United States. The rules it enacts have important consequences for the maintenance management, which makes the use of an effective CMMS solution almost essential.

Businesses in thepharmaceutical industry are particularly concerned by this standard, but other sectors are also affected. Les CMMS solutions new generations allow them to comply with them at a reduced cost, while improving their maintenance processes.

What is 21 CFR Part 11?

A short history of 21 CFR 11

In the 1980s and 1990s, advances in computer science prompted many companies to developdigital archiving of all of their documents. This allowed them to make archiving procedures faster, improve productivity, and reduce costs.

The pharmaceutical industry, in particular, quickly identified the benefits of implementing computerized systems at the level of operations of production units:

• increased speed of information exchanges;
• better approach to integration;
• trend setting;
• easier data search:
• reduction of errors and variability.

However, the computerization of document archiving did not then offer the same guarantees, in terms of reliability, validity and authenticity, as the paper methods used until then. La FDA (Food and Drug Administration), the American agency that sets standards concerning food and drugs, considered this situation to be problematic, because it allowed companies to falsify documents too easily and therefore to hide violations of the standards concerning them.

With the consequences for consumers being potentially serious, in particular in The pharmaceutical industry, the FDA therefore added 21 CFR Part 11 to the Code of Federal Regulations (CFR) in March 1997.

The main principles of 21 CFR Part 11

It is structured around two main axes:

• TheAudit Trail (the audit trail), whose objective is to keep track of any actions or changes that have occurred on the data or on the structure;
• The electronic signature, which aims to certify critical information or documents and, possibly, to comment on them.

The 21 CFR Part 11 standard thus requires:

• strict and advanced management user access and rights ;
• one log of connections and accesses, whether authenticated or not authorized;
• The definition of hierarchical patterns in particular, defining persons responsible for approving data for certain critical operations.

The pharmaceutical industry, the first sector concerned

Because of the considerable health and medical challenges that weigh on it, this traceability requirement was primarily addressed to the pharmaceutical industry. But it then extended to other industrial fields such asAgro-food Or the cosmetic.

Thus, companies in these sectors that want to market their products to u.s. must comply with this standard, set up by the FDA in order to avoid the sale of non-compliant products that could have serious health consequences.

Comply with 21 CFR Part 11 in maintenance

Digital archiving involves risks in terms of the reliability of information and goods. Complying with the 21 CFR 11 standard is not only an essential prerequisite for any penetration of the American market, but it is also a way to avoid possible production stoppages linked to health concerns that could generate significant additional costs.

Objectives of implementing the standard

The goals of implementing 21 CFR Part 11 reflect a desire for continuous improvement. In general, they result in the implementation of the following actions:

• eliminate the use of paper documents to reduce input errors, through a dematerialization and document management process (EDM, Electronic Document Management);
• acquire a computer traceability both upward and downward to save time when looking for maintenance action or information on a machine or products;
• computerize manufacturing and maintenance records and document flow management;
• Save time on the Feedback of information and problems, to reduce non-conformities.

CMMS at the service of the application of the 21 CFR Part 11 standard

In the field of maintenance, compliance with this standard has important consequences. Each step of the maintenance management must in fact comply with the rules it enacts. Have a CMMS software effective thus makes it possible to provide electronic records and signatures that meet the requirements of 21 CFR 11.

Of advanced functions also allow the management of the electronic signature with different levels of approval, access to records of all maintenance actions carried out, a high level of security, and expanded configuration possibilities. They also make it possible to monitor all changes and revisions made in maintenance settings and processes.

The new generation CMMS, a tool that complies with the 21 CFR Part 11 standard

Mobile CMMS software is the best tools for moving towards maintenance management in accordance with this standard, since they make it possible to gain in productivity and ensure easy handling.

Easily manage your privacy settings

Thanks to a new generation solution like Mobility Work, you can choose at any time the degree of confidentiality of all your data (equipment, spare parts, documents, etc.).

You can keep them private, share them only within your factory or industrial group, or make them public to benefit the community.

Mobile CMMS at the service of users

Implementing 21 CFR Part 11 involves several factors. : computer hardware, software, collaborators and procedures. In the field of maintenance, choosing a mobile CMMS software has a positive impact on each of these factors.

An application such as Mobility Work makes it possible to reduce the computer hardware required, to benefit from software that complies with the standard and is constantly updated, to greatly facilitate the task of the teams in charge of maintenance and to considerably simplify data entry procedures.

Mobility Work allows operators and technicians to be autonomous: checklists, task creation, maintenance plans, notifications for each new activity...

So entering information or data has never been easier. On a smartphone or tablet, users can save what they want from anywhere and at any time. Thanks to the application, you can thus integrate data or documents very easily, which improves the traceability of maintenance operations.

The transition to next-gen CMMS, child's play

Changes in software or maintenance management tools often scare business managers. With Mobility Work's new generation platform, it's quick and easy.

So you can import your data for free (lists of equipment and spare parts, maintenance history, maintenance plans, etc.) in the application, from any database, old maintenance management software or Excel file.

In a short time and at a reduced cost, adopting Mobility Work allows you to bring your maintenance management into compliance with US market standards while improving the reliability and ergonomics of your processes.