In the life sciences sector—including pharmaceuticals, biotech, and medical device manufacturing—regulatory compliance is not just a requirement; it’s a core business function. The FDA maintains strict oversight to ensure product safety and efficacy, making the choice of operational software a critical decision. For maintenance and asset management, selecting an FDA compliant maintenance software is essential for maintaining data integrity, ensuring audit readiness, and avoiding costly regulatory actions that can halt production and damage a company’s reputation.
A key regulation governing these operations is FDA 21 CFR Part 11, which sets the standard for electronic records and electronic signatures. This rule ensures that digital records are as trustworthy and reliable as their paper counterparts. Non-compliance can lead to significant consequences, including Form 483 observations, warning letters, and consent decrees. This article reviews the top five audit-ready CMMS solutions equipped with the necessary features to meet these stringent demands, helping you select a platform that protects your business and streamlines your maintenance workflows. For more information, see our resources on
Why Invest in a 21 CFR Part 11 Compliant CMMS?
Adopting a specialized CMMS is not just about checking a regulatory box; it’s a strategic investment in operational excellence and risk mitigation. This software provides a validated framework that strengthens data integrity, simplifies audits, and delivers a clear return on investment by preventing costly compliance failures.
Achieve Constant Audit Readiness
A compliant CMMS automatically creates a complete, unalterable electronic audit trail for every maintenance activity, calibration, and approval. This log includes who did what, when, and why, providing inspectors with a clear and verifiable record. This built-in documentation dramatically simplifies audit preparation and reduces the time and resources required to demonstrate compliance.
Guarantee Data Integrity
FDA 21 CFR Part 11 demands that electronic records are secure, authentic, and time-stamped. A compliant CMMS enforces this through features like unique user logins, role-based permissions, and secure electronic signatures. This ensures that all maintenance data is attributable and protected from unauthorized changes, meeting the FDA’s core requirements for electronic data.
Boost Operational Efficiency
Manual, paper-based record-keeping is inefficient and prone to human error. A compliant CMMS automates compliance workflows, from scheduling preventive maintenance to documenting corrective actions and capturing electronic sign-offs. This automation reduces administrative burden, minimizes the risk of documentation errors, and allows maintenance teams to focus on their primary tasks.
Mitigate Compliance Risk
The financial and operational impact of a regulatory finding can be severe. By implementing a validated CMMS, you proactively reduce the likelihood of receiving Form 483 observations or warning letters related to maintenance and calibration records. This proactive stance protects your operations from potential shutdowns and preserves your company’s standing with the FDA.
Improve ROI
Investing in compliant software is a strategic move that protects revenue. By preventing compliance-related production holds, reducing audit preparation costs, and improving maintenance efficiency, the CMMS delivers a tangible return. It transforms compliance from a cost center into a strategic asset that supports product quality and operational continuity.
How We Evaluated These CMMS Solutions
To identify the top solutions, we focused on criteria essential for success in a regulated life sciences environment. Our evaluation prioritized built-in compliance features, vendor validation support, and overall usability for maintenance teams to ensure the software is both compliant and effective in practice.
- Core 21 CFR Part 11 Functionality: We evaluated each platform’s built-in features for secure electronic signatures, detailed audit trails, role-based access controls, and record security.
- Validation Support & Documentation: We assessed the quality and completeness of the vendor’s validation package (IQ/OQ/PQ) and the availability of expert implementation support.
- Life Sciences Industry Focus: Priority was given to software with features and workflows specifically designed for pharmaceutical, biotech, and medical device manufacturing environments.
- User Experience and Adoption: We analyzed ease of use for both managers and technicians, as high user adoption is critical for maintaining compliance.
- Total Cost of Ownership & Vendor Reputation: We considered overall value, including implementation, support, and long-term viability based on industry reputation and user reviews.
Top 5 FDA Compliant Maintenance Software Solutions
Each CMMS on this list offers a path to 21 CFR Part 11 compliance, but they differ in their approach, core strengths, and ideal use cases. This breakdown will help you identify the best fit for your organization’s specific operational and regulatory needs.
eWorkOrders
Featured | Audit-Ready CMMS
eWorkOrders provides a comprehensive, cloud-based CMMS specifically designed for regulated industries. Its platform includes robust, built-in features to meet FDA 21 CFR Part 11 requirements, such as secure electronic signatures, detailed audit trails, and granular role-based access controls. With over 30 years of experience, the company offers not just software but a partnership, providing extensive support for the validation process (IQ/OQ/PQ). This focus on both technology and service ensures that life sciences companies can implement a system that is both powerful and audit-ready from day one, minimizing compliance risks and streamlining maintenance workflows.
Core Strength: Excellent balance of deep compliance functionality, user-friendly design, and top-rated customer support for implementation and validation.
Best For: Life sciences companies of all sizes seeking a scalable and proven FDA compliant maintenance software with a strong partner for validation and support.
Pro Tip: Leverage their experienced support team during the validation process to accelerate your implementation timeline.
Fiix by Rockwell Automation
Enterprise-Grade CMMS
As part of the Rockwell Automation ecosystem, Fiix is an AI-powered CMMS designed for large-scale, regulated manufacturing environments. It offers powerful tools for predictive maintenance and asset performance management, with compliance features to support 21 CFR Part 11. Its main advantage lies in its ability to integrate deeply with other enterprise systems, including manufacturing execution systems (MES) and ERPs. This makes it a strong choice for large organizations looking to create a unified data environment across their production and maintenance operations, leveraging IIoT and advanced analytics to drive efficiency while maintaining a compliant state.
Core Strength: Native integration capabilities with other enterprise systems like SAP S/4HANA and advanced IIoT and analytics features.
Best For: Large enterprises requiring a compliant CMMS that connects seamlessly with their existing manufacturing execution systems (MES) and ERP infrastructure.
Pro Tip: Plan for integration with your existing MES and ERP systems early to maximize the platform’s value.
Limble CMMS
Mobile-First Compliant CMMS
Limble CMMS is known for its modern, intuitive interface and rapid setup, making it a favorite among teams that prioritize ease of use. While its core product is broadly focused, its enterprise package includes the necessary features for 21 CFR Part 11 compliance, such as electronic signatures and audit trails. The platform’s standout feature is its exceptional mobile experience, which empowers technicians to manage work orders, log data, and access asset information directly from the field. This mobile-first approach drives high user adoption, which is critical for ensuring that compliance procedures are consistently followed by the entire team.
Core Strength: An exceptional mobile experience that drives high adoption among technicians and a guaranteed 99.9% platform uptime.
Best For: Organizations that prioritize a simple user interface and strong mobile functionality for their maintenance teams while needing to ensure audit readiness.
Pro Tip: Use the mobile app’s QR code functionality to streamline asset identification and work order updates.
UpKeep
Asset Operations Management
UpKeep positions itself as an Asset Operations Management platform, extending beyond a traditional CMMS to provide a holistic view of the entire asset lifecycle. For regulated customers, UpKeep offers a dedicated validation package to help meet 21 CFR Part 11 requirements. The platform’s strength is its ability to unify maintenance, reliability, and operations teams on a single system. This allows companies to manage everything from asset procurement and preventive maintenance to inventory control and capital planning within a compliant framework, providing better visibility and control over total asset performance and cost.
Core Strength: A unified platform connecting maintenance, reliability, and operations teams to manage assets from procurement to disposal with compliance in mind.
Best For: Companies looking for an all-in-one system to manage maintenance, inventory, and capital planning within a compliant framework.
Pro Tip: Integrate your procurement and maintenance workflows within the platform to better track total asset lifecycle costs.
FTMaintenance Select
On-Premise Compliant CMMS
For organizations with strict internal data control policies or IT infrastructure that prohibits cloud-based solutions, FTMaintenance Select offers a compelling alternative. It provides a fully-validated, on-premise deployment option that gives companies complete control over their data and system environment. The software includes the necessary modules for 21 CFR Part 11 compliance, ensuring that even facilities operating within a closed network can maintain audit readiness. This makes it a specialized solution for regulated manufacturing sites that require an on-premise system for data security, control, or other internal policy reasons.
Core Strength: Offers a robust, secure on-premise solution, giving companies complete control over their data and infrastructure for 21 CFR Part 11 compliance.
Best For: Regulated facilities with IT policies that prohibit cloud-based software or that require an on-premise system for data security and control.
Pro Tip: Ensure your internal IT team has the resources to manage and maintain an on-premise server environment.
Getting Started with eWorkOrders
Our process is designed to be straightforward, ensuring we understand your needs and provide a tailored solution that delivers immediate value.
- Tell us about your maintenance management needs (quick online form or call).
- Get a live demo of eWorkOrders CMMS/EAM software to see how it can simplify your maintenance operations.
- Start using an award-winning CMMS trusted by thousands of businesses across industries including manufacturing, healthcare, food & beverage, and facilities management.
- Work with our expert support team with 30+ years of experience delivering top-rated service, training, and implementation.
Why Choose eWorkOrders?
We combine proven technology with decades of industry expertise to deliver a solution that drives real business value and ensures regulatory compliance.
- Award-winning CMMS and EAM software trusted by thousands of organizations across manufacturing, healthcare, food & beverage, utilities, and facilities management.
- Over 30 years of experience delivering proven maintenance management solutions and exceptional customer support.
- Cloud-based platform with real-time visibility into work orders, assets, preventive maintenance, and inventory control.
- Flexible configuration, mobile access, and API integration to fit any organization’s maintenance workflows and compliance needs.
- Recognized by G2, Capterra, and Software Advice for Best Value, Ease of Use, and Customer Support.
Secure Your Operations with a Compliant CMMS
For companies in the life sciences, selecting a CMMS is a critical compliance decision, not just an operational one. The right platform transforms adherence to regulations like 21 CFR Part 11 from a manual burden into a streamlined, automated process that supports operational excellence. Choosing a vendor with deep experience in validated environments is key to a successful implementation and long-term audit readiness. By doing so, you protect your business from regulatory risk and build a more efficient, resilient maintenance operation. To see how our expert-backed platform can secure your business, explore our FDA compliant maintenance software. Book a demo today!
Frequently Asked Questions
What is FDA 21 CFR Part 11?
It is an FDA regulation that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records with handwritten signatures. It is essential for any software used to manage GxP data in regulated life sciences industries.
Can any CMMS be configured for 21 CFR Part 11 compliance?
No, true compliance requires specific, built-in features like secure, computer-generated audit trails, unique user logins, strict access controls, and logically-bound electronic signatures. A standard CMMS typically lacks these foundational security and data integrity functions needed to pass an FDA audit.
What is software validation and is it included with the CMMS?
Software validation is the documented process of demonstrating that the CMMS is suitable for its intended purpose within your specific operational environment. Leading vendors provide a validation package, including IQ/OQ/PQ templates and expert support, to guide your team through this critical process, though the final responsibility for validation rests with the user.
Is a cloud-based CMMS secure enough for FDA-regulated data?
Yes, reputable cloud CMMS providers designed for GxP environments utilize validated infrastructure with advanced security protocols, data encryption, and robust disaster recovery plans. These security measures often exceed the capabilities of what can be maintained for typical on-premise systems, providing a secure and compliant solution.
