New rules and regulations appear almost every day. The total number of rules and procedures any organization has to stay compliant with is mind-boggling. However, certain industries are required to adhere to more stringent compliance standards than others: food and beverage, pharmaceutical, cosmetics, medical device and others, where the lives of consumers depend on the quality of products manufactured in these facilities. Today, we’re looking at FDA 21 CFR Part 11 compliance and if a CMMS can help. Spoiler: no CMMS solution can be compliant itself. It can provide the tools organizations need to achieve and maintain compliance.
What is FDA 21 CFR Part 11?
Title 21 Code of Federal Regulations (CFR) is the policy that regulates the manufacturing practices of US Food and Drug Administration (FDA) related industries. FDA itself, Drug Enforcement Agency (DEA), and Office on National Drug Control Policy (ONDCP) all rely on Title 21 CFR to control food, drug, and numerous other public health products. Part 11 of this regulation specifically sets the requirements that electronic records and signatures must meet to be considered reliable, trustworthy, and have the same power as paper records. It also covers the standards of use for electronic signatures.
Although Title 21 CFR has been around since 1997, with the rise in CMMS use, many organizations are now curious if they can find a proper way to apply a CMMS from the compliance perspective. The reason is that creating a digital paper trail for the work done within facilities gives inspectors a chance to find necessary documents in seconds without looking through piles of paperwork. While Title 21 CFR part 11 describes hardware and software, electronic signatures, and program implementation, facility managers think that CMMS does part of this work. To some extent, they’re right.
How to stay compliant with Title 21 CFR Part 11 leveraging a CMMS?
A CMMS system can help organizations achieve compliance with federal codes, no matter if that’s Title 21 CFR 11 or any other regulation. A CMMS digitally monitors maintenance efforts by tracking work orders, providing the maintenance team with access to standard procedures and processes, tracking asset history, and more.
Fortunately, Maintenance Care can do it all and more! Maintenance Care is proud to support FDA regulated industries and organizations on their way to achieving compliance using the following features:
Preventive Maintenance: Our PM feature allows you to isolate preventive tasks that require special attention. This way, you can create comprehensive reports to sustain facility standards for compliance and audits. Determine the most crucial inspections to your organization and use equipment maintenance software to get organized by scheduling those inspections and keeping track of them. What’s more, you can attach specific files or documents to any PM task for your maintenance team—for example, MSDS forms, training PDFs, and safety documentation. Following work orders with each stage well documented and digitally verified by the maintenance team will provide you with detailed evidence of compliance when audit time comes.
Cloud Storage: Maintenance Care ensures not only the efficiency of your work order software but also the safety and security of all the files you upload to the system. Developing cloud storage, the team aimed at creating an environment that will make sure your files are backed up and secured from any outside access. To make it even more efficient, the Maintenance Care team has utilized the power of Amazon S3 server technology which lets you get access to the highly scalable, reliable, and secure infrastructure.
Parts and Inventory Tracking: Maintenance Care CMMS keeps a detailed log of work performed on all assets of your facility. This way, it’s easier for you, inspectors, and auditors to ensure equipment in your facilities is well-maintained and delivers expected results.
Maintenance Care can also help organizations focus on these five areas:
- Validation. If an organization uses an electronic system, like a CMMS, it’s required to validate the system “to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records <…> to ensure that only authorized individuals can use the system, access the operation or computer system input or output device, alter a record, or perform the operation at hand.” (for the full text of the FDA 21 CFR Part 11, click here). Maintenance Care will absolutely assist your organization with building this process.
- Audit Trail. Secure, computer-generated, time-stamped audit trails are also necessary to stay compliant. All edits are tracked within the Maintenance Care CMMS system with an audit trail.
- Legacy Systems. This part describes the requirements for systems that were operational before August 20, 1997 (the effective date of part 11). In short, if after this date the system has been changed, it must meet all the requirements of part 11.
- Copies of Records. Maintenance Care also offers the tool to “generate accurate and complete copies of records suitable for inspection, review, and copying.” The CMMS allows you to pull reports ad-hoc and schedule them in multiple formats.
- Record Retention. All data within Maintenance Care is retained for as long as the subscription is active.
Although compliance is about how a company uses the CMMS, not about the system itself, a CMMS is one of the best systems a facility manager can implement to ensure the tools needed to achieve and maintain compliance are available. To stay compliant with 21 CFR Part 11 and other regulations, contact the Maintenance Care team today and book a free demo to see the system for yourself!
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