21 CFR & Maintenance Compliance Software

Streamline Maintenance Compliance
Breeze Through Audits!

Ensure adherence to the conditions outlined by 21 CFR.

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41%+
Increase in productivity
37%+
Drop in downtime
$765M+
Saved in annual labor costs

Improve safety and compliance at every facility

Stay on top of preventative maintenance, avoiding dangerous malfunctions, and keep track of exactly when each machine was last inspected and serviced.

Prepare for audits

A robust CMMS simplifies 21 CFR compliance for your maintenance team, boosting overall operational efficiency.


Reduce Human Error

Automating compliance workflows reduces the burden of rigorous regulatory demands, minimizing manual mistakes and driving greater productivity.


Enhance Record Keeping

A compliant system ensures secure, accurate handling of all electronic signatures and records.


Automate maintenance scheduling

Automated scheduling guarantees critical tasks are completed on time with far less manual oversight.


Standard

Improve preventative maintenance and access real-time reports of your top KPIs.


Includes:
  • Limble Mobile App

  • Unlimited Assets and Custom Fields

  • Unlimited Work Orders and PMs

  • Unlimited Work Requesters

  • Unlimited Custom Dashboards

  • Automatic Downtime Reporting

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Premium+

Automate workflows and streamline inventory to increase efficiency and reduce costs.


Everything in Basic, plus:
  • Mobile App Offline Mode

  • Unlimited Spare Parts and Custom Fields

  • Vendor and Purchase Order Management

  • Meter and Threshold-based Scheduling

  • Open REST API Access

  • Customer Success Manager

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Enterprise

Optimize maintenance operations across multiple locations with advanced controls, integrations, and customization.


Everything in Standard, plus:
  • Multi-Location Tools and Reporting

  • Custom Roles and Approval Workflows

  • Inventory Cycle Counts

  • 21 CFR Compliance

  • Single Sign-On (SSO)*

  • ERP, IoT, and Business System Integrations*

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If your Order Form lists a plan not included here, please contact your Customer Success Manager for more details about such plans.

Spectrum Solutions

  • Reduce errors with work order templates, streamlined procedures, and accessible maintenance history.

  • Schedule preventive maintenance for optimal performance and compliance.

  • Track maintenance with electronic signatures and time stamps.

  • Record keeping with automatic backups, secure storage, and centralized access.

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FAQs

Yes. You can track maintenance with electronic signatures and timestamps, and keep accurate records with automatic backups, secure storage, and centralized access. 21 CFR compliance is included as part of our Enterprise plan.

Yes. Customers who purchase the 21 CFR version of Limble receive copies of all our validation documents, including our Risk Assessment, User/Functional Requirements, Validation Plan, IQ/OQ/PQ, and Trace Matrix. We'll walk you through the validation process and provide document templates if needed, and we share validation testing results with you before any software update goes live on your account.

Our Enterprise plan. It includes 21 CFR Compliance alongside Multi-Location Tools and Reporting, Custom Roles and Approval Workflows, Inventory Cycle Counts, Single Sign-On, and ERP/IoT/Business System Integrations.

Yes on calibration. Any asset can be set up with its own calibration schedule, with completion tracked and logged the same way as any other maintenance task, so you always know when equipment was last calibrated and by whom. Our 21 CFR version and validation document package support your Part 11 compliance efforts directly. Reach out to our team to talk through your specific GAMP 5 and CSV requirements.

A CMMS gives you the tools to meet Part 11 requirements, including electronic signatures, timestamps, secure record-keeping, and validation documentation, but your organization still has to perform the validated processes, maintain your SOPs, and train your staff. Many companies choose to accept our validation documents in place of running their own from scratch, though your Quality Department will always be the one to confirm your specific software validation requirements.