If you are a maintenance professional, especially in the medical devices, pharmaceutical or nutraceutical manufacturing space, you’ve probably heard the term “21 CFR” in reference to Title 21 of the Code of Federal Regulations. It covers a variety of requirements for which an FDA-regulated company needs to comply. While 21 CFR has been around for decades, many maintenance teams within manufacturing companies struggle with the specific requirements of 21 CFR, as well as understanding why it is so important and best practices for ensuring compliance without wasting precious resources.
Even though 21 CFR primarily applies to manufacturers of medical devices, pharmaceuticals or nutraceuticals, many different types of manufacturers must also comply if they make products (such as beverages, semiconductors or navigational instruments) that are used by manufacturers in those three industries. At the end of the day, it’s a very large percentage of manufacturers that must comply.
The importance of 21 CFR cannot be overstated, as it ensures product safety and efficacy and is vital in maintaining the public’s trust. Failure to comply could lead to anything from a warning to costly product recalls, and even shutting down a business entirely. To prevent this, maintenance teams often look for third-party support and other solutions to help simplify the compliance process. Here, we break down the specific requirements of 21 CFR compliance, the common roadblocks and struggles companies have with maintaining (and proving) compliance, and the role of computerized maintenance management systems (CMMS) in supporting this critical initiative.
To ensure all 21 CFR requirements are met, it is essential to understand them. It requires that businesses prove the safety and efficacy of their products. This is not only important from a business perspective, but critical for the health and safety of the general public. There are two portions of 21 CFR that are important for maintenance leaders to understand: Establishing Maintenance Schedules (21 CFR Part 820.70 (g) (1)); and Software Validation (21 CFR Part 820.70 (g) (3) (i)).
When it comes to the machinery involved in making their products, 21 CFR states that “each manufacturer shall establish and maintain schedules for the adjustment, cleaning and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.” Therefore, it is critical to document everything. When audited, every detail matters.
Using a CMMS is the industry best practice for managing maintenance schedules and records. If a software is used to manage anything that could affect the safety or efficacy of the manufacturer’s product, such as maintenance schedules, then validation must be completed. Software validation means that you have documentation to show that the way you are using your maintenance software complies with 21 CFR requirements, which state “when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.”
From there, organizations must perform validation testing. This requires a company to fully test the software and how that software is being used by the company. The validation consists of testing various aspects of the software, such as electronic records and signatures (21 CFR Part 11), how data is managed, and if the software is producing reliable results.
For both of these sections, documentation is critical. Without proper documentation, it is difficult to prove compliance during audits. Auditors will sometimes come unannounced, looking to identify weak points in the documentation that could lead to more significant maintenance problems. They look for proof of established and kept maintenance schedules and software validation. Manufacturers must be prepared at all times to satisfy an audit.
The requirements of 21 CFR are very specific and complex. While maintenance professionals are not required to know every detail about 21 CFR, they do need to be aware of the regulations for quality systems, computer systems and related electronic records. They also need to know what is required to pass an audit successfully.
Auditors come in looking for improper equipment maintenance, inaccurate or missing records, questionable security of software or documentation, difficulty finding a document or record associated with a piece of equipment, etc. They also look for validation testing for every new update or version release of a product or software being used in the manufacturing process. This can all be solved with proper documentation.
While documentation can be done with pen and paper, it is complicated, time-consuming, prone to errors and can be confusing to auditors, which may lead to failing audits unnecessarily. Organizations often look to their partners and vendors to assist, but often these partners offer very complex systems, don’t provide clear documentation or may contract with third parties that require additional costs and resources.
The gold standard to ensure 21 CFR compliance is to use a CMMS which helps businesses effectively manage, automate and refine their maintenance operations. Particularly when dealing with 21 CFR, a CMMS allows enterprises to seamlessly automate record tracking and automation, establish maintenance schedules so they are never missed, quickly retrieve past paperwork, maintain data integrity and ensure businesses are prepared for an audit at any time.
Of course, not all systems are created equal. There are a few things manufacturers should look for when selecting a CMMS. For example, providers should perform validation for every update or version release and be willing to share the results so manufacturers can easily reference them.
Additionally, the software should be easy and intuitive to use. This helps reduce the chance of missed maintenance schedules or lost documentation due to software complexity. Manufacturers should also look for a CMMS that was designed to be compliant with 21 CFR, particularly parts 820 and 11 as noted above.
Lastly, the CMMS provider should be able to provide a dedicated resource who is an expert in 21 CFR and can provide guidance. The right CMMS will result in significant cost and time savings, as well as ensure 21 CFR compliance when it comes to the maintenance schedules and software validation components.
Understanding 21 CFR is the first step toward ensuring data integrity, but figuring out the nuances of 21 CFR and its requirements can be incredibly challenging.
The most important thing to keep in mind is that auditors will make sure you have a documented process and that you are keeping safety and efficacy a priority in everything you do. Investing in solutions to ensure 21 CFR compliance protects your business, and it is a critical step in ensuring public safety.
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