Originally intended for the pharmaceutical sector alone, the 21 CFR Part 11 standard decreed by the American FDA now concerns more and more sectors. For companies destining their products for the US market, this standard has important consequences in terms of maintenance, because it forces to respect strict processes for the recording and archiving of all data.
It is therefore essential for these companies to choose a CMMS software that is adapted to these processes, that is to say a mobile, agile solution integrating Big Data.
The origins of the 21 CFR Part 11 standard
The FDA (Food and Drug Administration) created this standard in response to the growing computerization in the pharmaceutical industry.
The development of digital archiving
Thanks to the development of information technology, many companies set up digital archiving systems for their documents during the 1980s and 1990s. The pharmaceutical industry was one of the first to generalize this operating mode, which enabled it to hasten archiving procedures and improve productivity by reducing their costs.
More specifically, the implementation of computerized systems at the level of production units has made it possible to accelerate the exchange of information, to facilitate the data search, to reduce errors and variability and to establish trends.
The introduction of the 21 CFR Part 11 standard in the CFR
But these new techniques did not offer the same guarantees in terms of reliability, validity and authenticity, as the paper-based methods which were used until then. The FDA therefore decided to lay down rules to remedy this situation, which was deemed problematic. Indeed, they thought companies could falsify documents too easily, and therefore conceal their breaches of the standards to which they were subject.
Given the considerable stakes for consumers in the branches managed by the FDA (pharmaceutical and food mainly), the agency added article 21 CFR Part 11 to the Code of Federal Regulations (CFR, Code of Federal Regulations) in March 1997.
The consequences of the 21 CFR 11 standard for maintenance
The obligation to comply with this standard has important consequences for the maintenance of the industries concerned.
The main principles of 21 CFR Part 11 standard
This standard is built around two main principles. On the one hand, the audit trail, which must keep a record of any action or modification carried out on the data or on the production structure. On the other hand, the digital signature, the purpose of which is to certify important information, documents and comments.
Complete all maintenance activities in the CMMS to keep a record of all the interventions conducted by the teams
In practical terms, the standard requires a strict and advanced management of the user access and rights, a log of connections and access, whether authenticated or not, as well as a functional hierarchy diagrams defining the persons responsible for data validation on certain critical operations.
Meet the standard to improve the maintenance processes
Complying with the 21 CFR 11 standard is of course necessary for any company wishing to enter the American market. But it is also a way of improving the maintenance processes and thus avoiding production shutdowns linked to incidents, or suspension of incidents, due to IT security or health problems. The significant additional costs induced by these shutdowns will therefore be reduced or even erased.
The goal of applying this standard to the maintenance and management of computer data therefore fits into a global desire for continuous improvement. Practically, it results in:
- introducing an upward and downward IT traceability to facilitate the search for maintenance activity or information on machines or products;
- stopping the use of paper-based documents in order to reduce data entry errors, by means of a dematerialization and document management process;
- computerization of manufacturing and maintenance records, and management of the document flows.
Choose a performing CMMS software to meet the 21 CFR 11 standard
Having an effective solution is essential to fully meet the requirements of this standard, each stage of maintenance must comply with the rules this standard imposes.
The key requirements any CMMS software must meet
To comply with the 21 CFR Part 11 standard, a CMMS software must provide digital signatures and records that meet its criteria. The CMMS software must thus include advanced functions allowing the management of the digital signature with different levels of approval, an access to the recording of all the maintenance activities that have been carried out, a high level of security and expanded configuration possibilities.
The monitoring of all undertaken modifications and revisions must also be possible in the maintenance parameters.
CMMS 4.0, the most efficient solution
The latest technological innovations have enabled the emergence of next-gen solutions, such as the Mobility Work application. Thanks to these, meeting the 21 CFR Part 11 standard is easier than ever.
A mobile CMMS to facilitate the work of the teams
One of the main features of Mobility Work is that it is a mobile application, available in SaaS. This means it can be used from any smartphone or tablet. Data and information entry is therefore considerably facilitated, since it can be done before, during or after maintenance operations, on-site.
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For the teams in charge of maintenance, this represents a remarkable saving of time and energy, which encourages them to strictly adhere to the procedures of the standard decreed by the FDA. Users can even save a document at any time from anywhere in the application. This helps avoiding the loss of information and improving the traceability of maintenance operations.
Quickly manage privacy settings
Thanks to the next-gen CMMS, the level of confidentiality of all data can be easily and at any time determined by those responsible for their security. Data can thus be kept private, shared only within a plant or an industrial group, or made public for the benefit of the Mobility Work community.
Simple and quick installation
Unlike traditional software, introducing a 4.0 CMMS is extremely easy, which is a significant advantage for companies who want to quickly comply with the 21 CFR 11 standard. All existing data can therefore be imported, free of charge, into the Mobility Work application from any Excel file, database or former CMMS software.
Choosing a next-gen CMMS is therefore the best option to have maintenance that meets the 21 CFR Part 11 standard. The implementation is fast and the cost is reduced compared to outdated solutions. Teams also are more committed and capable of respecting processes thanks to technology.
