The 21 CFR Part 11 standard is mandatory for all companies selling products in the United States. Its rules have important consequences for maintenance management, which makes it almost mandatory to deploy an efficient CMMS solution.
Companies in the pharmaceutical industry are particularly affected by this standard, but other sectors are also impacted. Next-gen CMMS solutions enable them to comply with it at a reduced cost while improving their maintenance processes.
WHAT IS THE 21 CFR PART 11?
History of the 21 CFR Part 11 standard
In the 1980s and 1990s, progress in information technology prompted many companies to develop digital archiving of all their documents. This allowed them to make procedures faster, improve productivity and reduce costs.
The pharmaceutical industry, in particular, quickly identified the benefits of implementing computerized systems at production unit operations levels:
faster exchange of information;
better approach to integration;
easier data search;
reduction of errors and variability.
However, the computerization of document archiving did not offer the same guarantees, in terms of reliability, validity, and authenticity as the “paper methods” used until then. The FDA (Food and Drug Administration), the US agency that sets standards for food and drugs, found this situation problematic, as it allowed companies to falsify documents too easily and thus conceal breaches of their standards.
The consequences for consumers being potentially serious, particularly 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
This is based on two main things:
the audit trail, the objective of which is to keep track of any action or modification on the data or the structure;
the electronic signature, which aims to certify critical information or documents and, where appropriate, to comment on them.
The 21 CFR Part 11 standard thus imposes:
strict and advanced management of access and user rights;
a log of connections and accesses, whether authenticated or unauthorized;
the definition of hierarchical schemes defining, in particular, who is entitled to validate data on certain critical operations.
The pharmaceutical industry is the first sector concerned
Because of the considerable health and medical stakes involved, this requirement for traceability has been addressed primarily to the pharmaceutical industry. But it then extended to other industrial fields such as the food industry or cosmetics.
As a consequence, companies in these sectors that wish to market their products in the United States 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 THE 21 CFR PART 11 STANDARD IN MAINTENANCE
Digital archiving entails risks with regard to the reliability of information and goods. Compliance with 21 CFR Part 11 is not only an essential prerequisite for entering the US market but also a means of avoiding possible production stoppages due to sanitary suspicions, which could generate significant additional costs.
Objectives of the standard’s implementation
The objectives of the implementation of 21 CFR Part 11 result from a desire for continuous improvement. In general, they are reflected in the implementation of the following actions:
eliminate the use of paper documents to reduce input errors, through a process of dematerialization and document management (EDM, Electronic Document Management);
be equipped with computerized traceability both ascending and descending to save time when looking for a maintenance action or information on a machine or on products;
computerize manufacturing and maintenance files and document flow management;
save time on reporting information and problems to reduce non-compliance.
CMMS at the service of 21 CFR Part 11 implementation
In the field of maintenance, compliance with this standard has important consequences. Each stage of maintenance management must comply with the rules it lays down. Having an efficient CMMS software allows to provide electronic records and signatures that meet the 21 CFR Part 11 standard’s requirements.
In addition, advanced functions make it possible to manage electronic signatures with different levels of approval, access to records of all maintenance actions performed, a high level of security, and extended configuration possibilities. They also enable users to track all changes and revisions made to maintenance parameters and processes.
NEXT-GEN CMMS: A TOOL COMPLIANT WITH THE 21 CFR PATR 11 STANDARD
Next-gen software, or mobile CMMS, are the best tools for moving towards maintenance management that complies with this standard since they increase productivity and are easy to use.
Easily manage your confidentiality settings
Thanks to next-gen solutions like Mobility Work, you can choose the confidentiality level af all your data at any time (equipment, spare parts, documents, etc).
You can keep it private, share it only within your plant or industrial group or make it public to help the community.
Mobile CMMS at the service of users
Implementing 21 CFR Part 11 involves several factors: hardware, software, people and procedures. In the field of maintenance, turning to a mobile CMMS software has a positive impact on each of these factors.
An app such as Mobility Work makes it possible to reduce the amount of hardware required, to benefit from software that complies with the standard and is constantly updated, to truly facilitate the work of the maintenance teams and to considerably simplify data entry procedures.
Mobility Work CMMS allows operators and technicians to be autonomous: task creation, maintenance plans, notifications for every new activity…
So entering information or data has never been easier. On a smartphone or tablet, users can record what they want from anywhere at any time. The application allows you to integrate data or documents very easily, improving the traceability of maintenance operations.
Making the transition to next-gen CMMS child's play
Changes in software or maintenance management tools often frighten company managers. With Mobility Work's next-gen platform, it's quick and easy.
You can thus import your data (equipment and spare parts lists, maintenance history, maintenance plans, etc.) free of charge into 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 in line with US market standards while improving the reliability and ergonomics of your processes.