Thu. Jun 13th, 2024

The 21 CFR part 11 is a necessity for pharmaceutical companies selling products within the United States. The rules and regulations therein have vital outcomes for maintenance management which prompts the adoption of an effective CMMS solution.

Organizations in the pharmaceutical industry are pretty much affected by this standard and so are other sectors. The latest CMMS solutions enable them to follow this standard at a cheaper cost and implement processes consistent with the 21 CFR meaning and intent.

What is 21 CFR Part 11?


Between the 1980s and 1990s advancements in information technology enabled many organizations to archive their documents digitally. This enabled them to fasten procedures, reduce costs and increase their productivity.

The pharmaceutical business identified the advantages of implementing CMMS at the production level such as:

  • Simpler data research
  • Quicker information exchange
  • Identification of trends
  • Error reduction
  • Better integration approach

However, computerizing document archiving did not give the same results of validity, reliability, and authenticity as compared to the paperwork method. The Food and Drug Administration (FDA) –a USA agency that makes standards for drugs and food, found this a problem since it made it possible for organizations to easily falsify documents and hence hide details of their standards.

The consequences were serious to the consumers in the pharmaceutical industry, hence the FDA introduced 21 DFR Part 11 to the Code of Federal Regulations in 1997.

Major principles of 21 CFR Part 11

The principles of 21 CFR Part 11 are based on two major things:

  • Electronic signature

It certifies important information and comments on them 

  • Audit trail

This means keeping track of any modification or action on the structure or data

As a result, the 21 CFR Part 11 imposes:

  • Advanced and strict management of user rights and access
  • A log of accesses or connections both unauthorized or authenticated
  • Hierarchical structures define who in particular has the authority of data validation on crucial operations.

The Pharmaceutical industry.

Due to the medical and health stakes involved the requirement for traceability is common in the pharmaceutical industry. However, it extended to other fields such as the cosmetics and food industry. Hence companies in these sectors that need to market their goods and services in the USA must follow this standard to avoid selling non-compliant products that could otherwise have serious health consequences.

Comply with 21 CFR Part 11 

Digital archiving involves risks as far as the reliability of goods and information is concerned. Complying with 22 CFR Part 11 helps avoid stoppages in production caused by sanitary suspicions which could lead to more expenses.

Objectives of the CFR Part 11

The objectives of the standards implementation emanate from the need for constant improvement. They are shown in the implementation of the cations below:

  • Getting rid of paper documents for input error reduction via the process of document management and dematerialization.
  • Computerized traceability to make it faster when looking for maintenance information or action for a machine or on products.
  • Automate maintenance and manufacturing files and the management of document flow.
  • Time saved on problem and information reporting for reducing non-compliance.

How does CMMS help in the implementation of 21 CFR Part 11?

In the maintenance field following this standard has very critical results. Each level of maintenance management must follow the laid down rules. Having effective CMMS software enables the provision of electronic signatures and records that comply with the requirements of the 22 CFR Part 11.

High-tech functions enable it to manage electronic signatures with various approval levels access all records of performed maintenance activities, high-security level, and an extended configuration. Users are also able to track the revisions and changes made to maintenance processes.

Benefits of a CMMS software compliant with the 21 CFR part 11 standard

Mobile CMMS software is the best system for propelling organizations toward maintenance management that conforms to this standard since they are easy to use and fosters productivity. Some of the benefits are:

Manage your confidentiality settings with ease

Modern CMMS software enables the technicians to select the level of confidentiality of all the data at any given time i.e. spare parts, equipment, documents, etc. You can also make it private for sharing it with only your facility group or publicize it to help the community.

Mobile CMMS

The implementation of 21 CFR Part 11 requires various factors like software, hardware, procedures, and people. In the maintenance field adopting a mobile CMMS software impacts each of these factors positively.

It is possible to minimize the amount of needed hardware with a simple app, the software complies with the requirements and is updated frequently, facilitating the work of the technicians and simplifying the data entry processes.

Data input has never been made easier. The users can input what they want from any location in real-time on a tablet or smartphone. You can be able to integrate information or data simply and improve the traceability of the maintenance operations.

Transitioning to CMMS

Software changes usually frighten maintenance managers. It is simpler and quick when using mobile software. You can be able to input information i.e. part and equipment lists, maintenance plans, and maintenance history at zero cost into the software from any old maintenance management application, database, or excel file.

Within a short time and at a reduced cost adoption of mobile CMMS software enables you to bring your maintenance management work in tandem with the US market regulations while also improving the ergonomics and reliability of your process.

In summary, compliance with the 21 CFR Part 11 is mandatory for the smooth running of your facility. You can stay within the safety standards which in return will save you unwanted expenses when there are irregularities in the production process. Therefore, if you are running a facility associated with food and drugs it is also important to adopt a 21 CFR Part 11 compliant CMMS software to make the smooth running of the facility.

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