Maintaining compliance amid tens of thousands of regulatory standards can be a major challenge for companies in the life sciences sector, which remains among the most regulated industries. From over-the-counter medications to medical devices and equipment, people’s lives can depend on these products, which require strict standards to ensure safety.
Maintenance technicians in the life sciences play a key role in meeting these standards. It is critical for maintenance professionals to maintain thorough, accurate records for compliance with local, state, federal, and international regulations. In addition, managers must be able to track their team’s activities and give workers centralized access to processes and procedures, while ensuring accurate maintenance documentation in the event of an audit. This is where a computerized maintenance management system, or CMMS, comes into play.
Historically, many maintenance operations have relied on paper records and binders. However, this method is time consuming and prone to error. Now, with advances in automation, there are much easier ways to track compliance. A CMMS is a powerful tool to streamline maintenance management, comply with regulatory standards, and effectively migrate from paper records to electronic documentation.
What is 21 CFR Part 11?
One of the most important regulations that applies to electronic recordkeeping for the life sciences is 21 CFR Part 11, which establishes U.S. Food and Drug Administration regulations on electronic records and signatures. It governs how FDA-regulated companies must handle their electronic records and quality review processes to be considered trustworthy.
21 CFR Part 11 confirms that a life sciences company has sound business practices. It requires changes made to the program to be recorded in a clearly documented audit trail. It demands documentation of who has the authority to make those changes via electronic signature. And it expects the ability to demonstrate that the system is operating within a validated state.
This ensures that the data is accurate, reliable, authentic, and equivalent to handwritten approvals.
The right CMMS software supports 21 CFR Part 11 requirements by creating a digital paper trail, increasing reliability and repeatability and enabling digital signatures.
21 CFR Part 11 compliance with CMMS Software
Maintenance and engineering teams in the life sciences sector should be aware of a handful of critical areas covered by 21 CFR Part 11. Some of those include the analysis of procedural documentation, computer system validation, and audit data.
Particularly in the life sciences, maintenance management software needs robust reports and dashboards, plus quick asset history access and preventive maintenance tools that help with compliance and audit readiness. Having a tool with configurable reports and dashboards can make the difference between a painful audit and a company passing with flying colors.
That will include easy electronic maintenance documentation for essentials like completing work orders, scheduling equipment, cataloging spare parts, managing maintenance storerooms, and tracking technicians’ maintenance activities. In the past, only paper records could be provided to an auditor for an FDA inspection. Today, maintenance software makes it much easier to display digital documents on a ready-to-view dashboard.
So, when it comes to industry best practices, life sciences CMMS software should have the necessary requirements for compliance. Yet it still must empower maintenance teams to quickly complete their day-to-day tasks.
Beyond having an easier, more efficient system, maintenance teams also can reduce errors, lower overall costs, and improve safety. The below four areas highlight some of the most common improvements for maintenance teams looking to be better prepared for 21 CFR Part 11 software requirements.
4 ways to use CMMS for 21 CFR Part 11 compliance
1. Automatic work order tracking
Work orders are the heart of any maintenance team. A large MRO team can complete tens of thousands — or even hundreds of thousands — of work orders in a year.
That’s why comprehensive compliance evidence is crucial for maintenance teams. An auditor should be able to track work orders from creation to completion. Every stage should be documented and digitally verified by a staff member. We’d love to take Johnny Appleseed’s word, but it’s also essential to be capable of running reports for compliance that show on-time work order completion.
For maintenance teams stuck using paper work orders, this is a daunting task. However, once those records are digitized using a CMMS, organizations can reduce their audit stress thanks to easily accessible data. Of course, they can also eliminate hours spent logging work by hand or running back to a shop.
2. Documented maintenance best practices
Within a CMMS, maintenance managers can also attach relevant regulation-specific documents to their work orders for reference. That may include anything from safety documents such as lock out, tag out (LOTO) to instruction and OEM manuals, or helpful diagrams. Organized facility and asset records can ensure work will be completed safely, efficiently, and according to the manufacturer’s recommendations (not to mention the time savings of walking back to check a binder).
As a result, the system is well-positioned to improve accuracy, as technicians follow standardized processes and procedures, like mandated work order signoffs that show a quality review. Looking beyond compliance, a complete asset work order history also gives maintenance teams a comprehensive picture of asset health.
3. Immediate proof of compliance
If you’ve ever spent hours in spreadsheets manipulating data, this is for you. KPIs are vital to maintenance teams, enabling them to turn current and historical CMMS data into insights that enable future data-driven decisions.
Whether it’s customer audits, FDA audits, or performance reviews, maintenance leaders often rely on personalized dashboards and reports for visibility. A life sciences CMMS should offer pre-loaded reports in addition to configurable and flexible report creation that help provide proof of compliance to auditors and inspectors.
4. Real-Time alerts and automation
In addition to routine maintenance tasks, a technician’s day is typically filled with firefighting, work-order backlogs, and new requests. Real-time alerts help organizations stay on top of compliance tasks and ensure audit readiness.
Remembering to update each individual record at the end of the day can be challenging. Enabling technicians to be mobile while responding to live alerts reduces turnaround time while maintaining compliance. The documented work-order processes and procedures maintain compliance with FDA regulations by providing a time and date stamp of the updates.
Compliance audit readiness challenges a CMMS can’t fix
Adding a CMMS for compliance purposes can streamline tasks and add visibility to an already excellent compliance program. But without solid operational processes in place, life sciences compliance can still be a challenge. Here are a few common compliance challenges a CMMS can’t solve alone.
Poorly defined or inconsistent procedures
A CMMS can enforce workflows, but it can’t fix unclear or outdated procedures. Auditors look for alignment between procedures, executed work, and CMMS records. Differing practices from site to site, inconsistently used procedures, or procedures that don’t reflect actual maintenance practices can all result in poor audit performance and unnecessary headaches.
Incomplete or inaccurate maintenance documentation
While a CMMS is the best way to prove compliance, it only works when technicians and other employees thoroughly and accurately document their tasks. Work orders closed without meaningful notes, missing as found/as left condition information, or with poorly documented workflows must all be addressed for the CMMS to provide complete documentation. To an auditor, if it wasn’t documented, it didn’t happen — and that can cause a serious problem.
Lack of CMMS validation or revalidation
Not every CMMS is compliant with audit trail requirements under GMP or 21 CFR Part 11. Requirements like documented validation lifecycle, system validation after updates, and electronic signature controls are necessary to prove compliance. If the CMMS doesn’t already have these components built in, successfully passing audits may be a challenge, even if you’ve perfectly documented everything.
Calibration and maintenance data silos
Calibration is especially sensitive in life sciences, where even slightly incorrect processes can have long-term effects on end users and company reputation. If calibration records are stored separately from the CMMS, they’re not easily available to auditors, making it that much harder to prove compliance.
Even the best CMMS compliance software can’t make your organization audit ready if the data isn’t accurately documented and stored in the CMMS. And if the CMMS wasn’t built with audit readiness in mind, it may be missing key features required by GMP and CFR 11 Part 21.
Execution gaps vs system capability in CMMS compliance
In regulated life science environments, compliance failures are often attributed to CMMS limitations. However, the more common problem is an execution gap. The system capabilities exist, but day-to-day practices don’t take full advantage of them.
One frequent gap appears in change control. Although a CMMS can track asset histories and maintenance changes in detail, updates to preventive maintenance tasks, frequencies, or equipment configurations are often made without review or documented impact assessments. When these changes don’t follow established change control processes, traceability and validation status break down.
User access and permissions are other areas where organizations can face compliance challenges. Role-based access, audit trails, and electronic signatures are standard CMMS compliance features, yet many organizations don’t carefully control system access. Shared passwords, overly broad access, and failure to perform regular access reviews undermine accountability and create data integrity risks.
Even when preventive maintenance programs are well established, compliance risk remains if PM strategies aren’t defensible. CMMS tools can schedule and track PMs effectively, but missed tasks or PM frequencies that lack a risk-based rationale are common audit findings. Completion alone isn’t enough. Organizations must be able to justify why their maintenance strategy is appropriate for each critical asset.
Finally, oversight and review often fall short. CMMS compliance workflows may support supervisory or QA review, but if work orders are closed without supervisory sign-off, there’s no audit trail and no proof of control.
A CMMS can enable compliant processes, but inspectors ultimately assess how those processes are executed in practice. These examinations often reveal gaps between internal assumptions and external regulatory expectations.
Inspector expectations vs internal assumptions
Many organizations are plagued by a common disconnect between internal assumptions about what auditors are looking for and what they’re actually looking for. Overcoming these assumptions requires understanding the reasoning behind the goals of an audit.
- Assumption #1: Using a CMMS equals compliance
- Regulators assume that systems support processes rather than replace them. Auditors expect to see consistent execution, review, and justification behind CMMS compliance data.
- Assumption #2: Completing tasks is enough
- Inspectors are looking for more than just completion. They’re looking for rationale of PM tasks and frequency, criticality assessments, and process reviews that prove the tasks are risk-based and necessary.
- Assumption #3: An audit trail means data integrity
- Data must be attributable and protected from inappropriate modification. If audit trails aren’t reviewed and access isn’t controlled, inspectors may conclude the audit trail is insufficient.
- Assumption #4: Local flexibility is acceptable
- Inspectors look for consistent execution across shifts, teams, and locations. Even minor deviations from standardized procedures may be interpreted as a lack of compliance or a loss of control.
Inspectors audit the system, but they also look at user behaviors, decisions, and proof of process control. A CMMS can only prove compliance when internal actions line up with inspector expectations in these areas.
The eMaint CMMS provides audit trails, built-in calibration and preventive maintenance documentation, and digital signatures critical for audit compliance. Equally as important, the eMaint implementation process helps ensure those capabilities are used consistently and in alignment with regulatory expectations from day one.
Discover how eMaint helps bridge the gap between CMMS capability and compliant execution with a free demo.