21 CFR Compliance: How Your CMMS Is Your Audit Insurance

If you manufacture pharmaceuticals, medical devices or any other FDA-regulated goods, you know the stakes are astronomically high. We’re not just talking about equipment uptime; we’re talking about public health and the legal integrity of your entire operation. In this world, the paper trail behind every wrench turn, calibration and repair is as critical as the maintenance itself. This is the world of 21 CFR compliance. We need to treat our maintenance records not just as checklists, but as legal documentation.

What Is 21 CFR & Why Is It Your North Star?

If the U.S. Food and Drug Administration (FDA) regulates what you make, the Code of Federal Regulations, Title 21 (21 CFR) is your non-negotiable legal framework. It is the set of rules established by the FDA and published via the federal register and the Office of the Federal Register (OFR) that governs everything from how you manufacture and package products to the quality assurance systems you must have in place. 

For maintenance and asset management teams, 21 CFR acts as a compass pointing directly toward operational excellence — and absolute accountability. This huge set of regulations, sometimes referred to as Title 21 of the Code of Federal Regulations, is divided into various sections (chapters and subchapters) and parts, each managed under the authority of the Department of Health and Human Services. Failure to achieve regulatory compliance with any part of the CFR title is not a minor inconvenience; it can lead to warning letters, product recalls, facility shutdowns and devastating fines. As such, it’s the job of maintenance professionals to ensure the integrity of the assets that produce these critical products. That integrity is proven entirely through compliant, auditable documentation.

Industries Where Non-Compliance Is Not An Option

Compliance is mandatory across several major sectors. If your job involves maintaining equipment in these regulated industries, your work falls directly under the 21 CFR microscope:

• Pharmaceuticals: Ensuring new drugs and over-the-counter medications meet purity, potency and safety standards through current good manufacturing practice (cGMP), formerly known as good manufacturing practices (GMP).
• Medical devices manufacturing: Following Quality System Regulation (QSR) to ensure devices are safe and effective, which can include rigorous premarket approval processes and ongoing medical device reporting and post-market surveillance.
• Biotechnology and life sciences: Governing the development, testing and production equipment, often involving human subjects and the work of clinical investigators in studies governed by good laboratory practice.
• Food and consumer products: Certain sections, like the federal food regulations, apply to food products, food additives, dietary supplements and even animal feeds, ensuring proper sanitation and monitoring for residues. This also includes strict regulation of tobacco products. Compliance with these rules contributes directly to public health. (Note: The Drug Enforcement Administration also plays a regulatory role, but is distinct from the FDA’s core 21 CFR authority).

The Stakes: Why 21 CFR Is Critical For Maintenance Teams

The FDA doesn’t just regulate the product; they regulate the process — and your assets are the core of that process. Every piece of equipment, from the reactor vessel to the smallest calibration tool, must be maintained under tight control. The requirements laid out in parts like 21 CFR Part 211 (drugs) and 21 CFR Part 820 (medical devices) place the burden squarely on the shoulders of maintenance teams.

That means providing definitive proof that the equipment is suitable for its intended purpose and hasn’t been compromised. This translates into three critical demands for maintenance teams:

1. Mandatory equipment maintenance: Your team must have documented standard operating procedures (SOPs) for the scheduled cleaning, adjustment and maintenance of production equipment. This is essential for upholding current good manufacturing practice. These maintenance records must demonstrate that preventive maintenance (PM) was performed before failure, not reactively.
2. Calibration records: For inspection and testing equipment — tools used to verify product quality control — routine calibration is not optional. Section 820.72 requires documentation showing calibration standards, dates and the individual completing the work orders.
3. Data integrity: The work orders you close, the checklist you sign and the PM you perform serve as legal documentation. They must be accurate, legible, permanent and readily retrievable during an inspection or audit. Missing a signature or misfiling a paper record can instantly turn a compliant process into a deviation.

Zero Tolerance: Understanding 21 CFR Part 11

In the modern maintenance world, paper is an Achilles’ heel. It’s slow, prone to errors and impossible to scale. That’s why the FDA created 21 CFR Part 11. This is the regulation that gives electronic records and electronic signatures the same legal weight as their paper counterparts. Think of Part 11 as the rule set that makes your digital documents — your data — legally binding.

This is where most maintenance teams hit a wall. Using a basic software isn’t enough; the software must have built-in controls to ensure absolute data integrity. Part 11 boils down to three core requirements for your computerized maintenance management system (CMMS):

System Validation

You must be able to prove, through documented procedures, that the CMMS or maintenance software is accurate, reliable and consistently performs its intended functions. In short, you must perform computer system validation (CSV) to ensure your software does what your SOP says it does.

The Unbreakable Audit Trail

This is the heart of Part 11. Your CMMS must automatically generate an audit trail that captures every action performed on an electronic record. If a technician changes a work order status, edits a meter reading or simply opens and views a document, the system must log:

• Who performed the action
• What the action was (the old value and the new value)
• When the action occurred (date and time stamp)

The audit trail must be secure and unalterable, ensuring the history of the electronic data is never in doubt.

Electronic Signatures

Part 11 ensures that an electronic signature is legally equivalent to a handwritten one. For a signature to be compliant, it must contain:

• The printed name of the signer
• The date and time of the signature
• The meaning of the signature (e.g., “Approval,” “Review,” or “Completion of work”)

Furthermore, the system must enforce strong security, linking the signature only to the intended individual through unique user IDs and passwords.

Your 21 CFR Part 11 Compliance Checklist

Before an FDA auditor walks through your door, your maintenance operation must be able to answer “yes” to every item on this checklist. This is what we focus on when building a regulatory compliance program:

• System validation is documented: We have documented proof that the CMMS performs accurately and as expected.
• Audit trails are enforced: The system automatically generates unalterable, time-stamped records of all creation, modification or deletion of maintenance data.
• User access is restricted: Unique logins, strong passwords and granular user permission controls are enforced to limit access to only authorized personnel.
• Electronic signatures are compliant: Signatures include the user’s name, the date/time and the meaning of the signature.
• SOPs and training are current: All users are trained on the documented SOPs for the electronic data system, and training records are recorded.
• Data backups and retention are robust: Records are securely backed up, easily retrievable and maintained for the required regulatory compliance period.

Coast: The Customizable CMMS For Audit Readiness

We know that strict, high-stakes environments demand a tool that moves at the speed of your team but is backed by ironclad controls. Here’s a critical truth: No CMMS is inherently 21 CFR compliant. Compliance is achieved by how you use the software. However, Coast is designed to give you the foundation to build that compliant process.

Coast is built on the philosophy that control shouldn’t come at the expense of efficiency. We give your maintenance team the flexibility to customize work orders while building secure, electronic records in the background. We do this with:

• Unbreakable audit trails: Coast’s detailed logging for every action — from a new work order created to a meter reading edited — creates a secure, non-repudiable history. This is your defense when an auditor asks, “Who did this and when?”
• Data integrity enforcement: You can customize fields and work orders to ensure critical information is always captured. If the maintenance manager needs the reason for a PM deviation, you can make that field mandatory before the work order can be closed. This also assists in documenting corrective action preventive action (CAPA).
• Document control and SOP integration: Regulatory compliance relies on linking maintenance actions to regulatory documentation. Coast allows you to attach SOPs, equipment manuals and calibration certificates directly to the asset or the work order itself. This eliminates the risk management issue of using outdated documents.

When we designed Coast, we made sure that it could securely handle all the core requirements of 21 CFR Part 11 — user security, access controls and detailed audit trails — so your team can focus on their jobs, not on paperwork.

 Key Features Coast Provides for 21 CFR Compliance

Compliance can’t be a bureaucratic headache; it needs to be intuitive. Our software includes features that facilitate the compliance workflow easily, especially in the field. 

• Custom work order forms: A core feature is the ability to create customizable forms. This is key for regulatory compliance because it enforces data integrity consistency — a non-negotiable requirement. For a critical preventive maintenance task, we can set up a required electronic signature field, forcing the user to select the Meaning of Signature (i.e., “I confirm all steps were completed”) from a mandatory drop-down before they can submit the form. This is essential for batch records.
• User permission controls: Not everyone should be able to approve a critical spare part, initiate a change control or apply for an exemption. Coast lets you limit editing, deleting or final sign-off authority to specific, authorized personnel, ensuring only verified users are touching sensitive electronic records.
• Mobile-first documentation: Regulatory work happens next to the equipment. Coast’s mobile-first design means technicians can complete their work order, attach photos and apply a compliant electronic signature immediately, right from the floor. This eliminates the non-compliant process of scribbling notes on paper to be entered later — a common point of failure for data integrity.

Factors to Consider When Choosing a CMMS for 21 CFR Compliance

Choosing a CMMS in a regulated environment is a strategic decision, not a purchasing decision. Beyond features, consider how the vendor supports your compliance efforts in the following ways:

• Ease of use drives compliance: If the system is cumbersome, your maintenance team will find workarounds — such as using external spreadsheets or paper — creating an instant compliance gap. The simpler the user experience, the higher the adoption rate and the more trustworthy your electronic records will be.
• Future-proofing and scalability: As your operation grows and the code of federal regulations evolve, you need a system that can adapt. Choose a CMMS that can handle complex asset tracking structures and integrate with other validated systems without compromising quality control.

Conclusion: Your Proactive Compliance Strategy

21 CFR compliance is not a static state; it is a continuous, documented strategy. For maintenance and asset management teams, this means transforming every routine task into an auditable event. Risk management is simplified when your maintenance processes are locked down. The right CMMS is not just a tool for scheduling; it is your audit trail insurance policy.

Coast provides the secure, customizable software platform that enables your team to enforce strict controls while maintaining the agility needed to run a complex, high-stakes facility in regulated industries.

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