Many industries, such as the life sciences, must meet strict regulatory requirements for facility management, equipment validation, and product safety. But that’s only part of the equation.
Your Quality Management System (QMS) must be compliant, too — and that includes the computerized systems you use to monitor, record, track, and store data and reports.
As with the equipment validation process, you must validate your computer software, too. Here’s what life sciences organizations need to know about CMMS validation.
What is Computer System Validation (CSV)?
Computer System Validation (CSV) is a process for proving that an organization’s electronic tools conform to applicable compliance standards. Improperly validated computer systems can violate regulatory requirements, putting privacy and safety at risk.
CSV isn’t a one-time process; when teams make any changes to computer systems, they must revalidate.
The life sciences and other high-risk industries require CSV for all computer systems and software. But specific systems have unique CSV requirements — for example, maintenance teams must validate CMMS tools.
What is CMMS validation?
Computerized maintenance management system (CMMS) validation is a form of CSV specific to CMMS software. The process ensures proper installation, configuration, and testing of new or updated CMMS software to meet regulatory standards and pass compliance audits.
While modern CMMS systems can support and simplify your validation process, it’s important to note that there’s no such thing as a pre-validated CMMS. Instead, CMMS vendors work with each client to customize their CMMS according to their specific compliance requirements.
Validated CMMS tools offer audit preparedness through organized, compliant recordkeeping, preserving data integrity. They play a key role in Quality Management Systems (QMS), ensuring and documenting product quality and safety. And by automating compliance practices, validated CMMS software reduces manual work associated with audit preparations.
What is revalidation for CMMS software?
Whenever a company implements or updates a CMMS tool, revalidation is necessary to maintain compliance. Significant updates requiring revalidation include:
- Implementing a new CMMS
- Upgrading your CMMS to a new version and/or adjusting core functionality
- Adjusting the breadth or depth of your CMMS usage within your operations
- Reforming your IT infrastructure, such as implementing new operating systems or servers
Who is responsible for the CMMS validation process?
Most organizations regulated by the Food and Drug Administration are required to validate the software tools used for maintenance management, such as CMMS software. That includes many organizations in the pharmaceutical, medical device, biotechnology, clinical research, food and drink, and cosmetic fields.
Neither the FDA nor your CMMS provider is responsible for CMMS validation. As the organization using a CMMS to record maintenance procedures and tasks, you are responsible for the validation process.
But good CMMS software vendors will support you throughout the process, including initial onboarding and confirmation of regulatory compliance, assistance with questions or challenges you encounter along the way, and revalidation when you make changes to your CMMS.
While you’re responsible for ensuring compliance and performing validation, that doesn’t mean you have to do it alone.
What life sciences teams validate to ensure compliance in CMMS tools
The CMMS validation process verifies that your maintenance management software collects clear, truthful, comprehensive, and unmodified data. That means you’ll validate the following aspects and features of the tool.
Data integrity
Data integrity means creating and storing accurate, consistent records of your tasks (including maintenance tasks). One way to measure this is through ALCOA guidelines, meaning all tasks and data are:
- Attributable (establish clear links between completed tasks and the specific people who performed them)
- Legible (kept indefinitely and readable by humans and/or computers)
- Contemporaneous (created while the task is performed)
- Original (unaltered, ensuring verified copies don’t distort content or meaning)
- Accurate (truthful representations of tasks performed)
A properly validated CMMS supports data integrity through compliant data capturing and recordkeeping processes.
Maintenance management processes and tasks
Your CMMS collects data about all maintenance activities, including preventive maintenance schedules and tasks. But compliant life sciences teams must document processes, too.
That means, in addition to your CMMS tracking and logging data associated with the execution of all inspections, calibration, corrective actions, and equipment replacement, you must also have a QMS with documented procedures for each of those tasks.
Your CMMS should demonstrate compliance through adherence to clearly documented procedures and routine maintenance scheduling practices.
Good practice standards
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are regulatory agencies that set compliance standards for highly regulated industries in the United States and the European Union, respectively.
If you’re a life sciences organization based in these regions or conduct any activities in them (including selling products), you must stay compliant with the regulations set by these organizations.
For good practice industry standards in the life sciences, these are the audit trail requirements a CMMS must meet (and help your organization meet):
- Good Practice (GxP) compliance software guidelines for FDA-compliant maintenance software
- Good Manufacturing Practice (GMP) guidelines for EMA compliance
Electronic records validation and digital signature standards for validated CMMS software
Both the FDA and EMA have set requirements for electronic recordkeeping and signatures, designed to ensure that digital maintenance records are as accurate as paper records. If your CMMS submits electronic data for regulatory filings, you must be compliant with these regulations:
- 21 CFR Part 11 CMMS requirements for FDA compliance
- EudraLex Annex 11 compliance requirements for EMA compliance
As with GxP and GMP, the 21 CFR and Annex 11 standards are similar to one another. They both:
- Identify all computer systems and operating environments
- Determine how regional and federal regulations impact your QMS and other computer systems
- Evaluate procedures
- Analyze process documentation and audit trails
- Assess computer system impact on regulatory compliance
How to validate CMMS for life sciences teams
How does CMMS validation work? The specific details and action items may vary based on your unique company requirements, but there are three main stages every organization must complete.
Step 1. Installation Qualification (IQ) for configuration and infrastructure testing
Installation Qualification is the first step. In the IQ stage, you must validate that you’ve properly installed and configured your CMMS software and that your infrastructure can support it.
That includes having on-prem or cloud servers with sufficient storage, power, and memory to keep your CMMS functioning reliably — and failsafe systems to minimize or eliminate downtime.
IQ ensures you’ve configured your CMMS for regular, reliable use.
Step 2. Operational Qualification (OQ) for CMMS feature testing
Next, you’ll assess the functionality of your CMMS. You’ll perform tests to observe manual and automated data collection and storage processes, confirm appropriate access controls, and validate alarm and notification triggers.
Operational Qualification ensures that your CMMS performs essential functions for normal operations and compliance audits.
Step 3. Performance Qualification (PQ) for CMMS reliability testing
The final stage of the validation process evaluates how well your CMMS software performs under both normal and extreme conditions.
You’ll run tests based on everyday operations, logging data and generating reports at your plant’s typical frequency and volume. You want to see how the software handles your daily workload.
Of course, some days are more demanding than others. Run stress tests that exceed your typical demands, aiming to overload the software. This enables you to test recovery and backup tools.
Performance qualification ensures that your CMMS runs reliably, avoiding inconsistencies and outages.
Official CMMS validation resources for compliance audit preparation
Your CMMS provider should be available to assist with software validation and answer your questions. However, these resources can provide more background, context, and insight to enhance your understanding of compliance requirements for CMMS tools:
- FDA software validation principles: While originally published in 2002, the FDA still references its General Principles of Software Validation document for industry best practices. You can learn more and download the document here: General Principles of Software Validation
- 21 CFR Compliance Requirements: Check out the complete FDA code here: CFR – Code of Federal Regulations Title 21, or review official guidance for Part 11 here: Guidance for Industry Part 11, Electronic Records. Additionally, we’ve written a helpful guide for 21 CFR Part 11 Compliance Best Practices, outlining what all life sciences organizations should know.
- EMA EudraLex Annex 11 GMP Requirements: To view GMP guidelines, including full text and summarized guidance, see the EMA’s official documentation here: EudraLex Annex 11 (Volume 4)
- ISPE GAMP®: The International Society for Pharmaceutical Engineering (ISPE) produces a valuable guide to compliant computer systems for pharmaceutical manufacturing and supply chain organizations, known as the Good Automated Manufacturing Practice (GAMP) guide. You can purchase the guide or review webinars, videos, white papers, and more here: ISPE GAMP.
How modern CMMS platforms support compliance validation processes
You’re responsible for CMMS validation — but between everyday maintenance operations, onboarding and training, and other compliance requirements like equipment validation, it can feel like an overwhelming burden. That’s why the right CMMS vendor should be with you every step of the way.
A robust CMMS for the life sciences industry should include these features:
- Centralized maintenance management records for all maintenance tasks from calibration to repairs, including electronic signatures, time stamps, and indefinite storage
- Compliance audit trails and documentation for facility maintenance, equipment validation, and technician qualifications
- Comprehensive asset management tracking for proper equipment maintenance and data-driven decisions on repair or replacement
- Work order creation, tracking, and supporting documentation for both preventive maintenance tasks and reactive maintenance procedures, including templatized standard operating procedures (SOPs) and checklists
- Contemporaneous data creation with real-time visibility and reporting for everyday practices, safety incidents, and audits
- Tool and sensor integration to monitor equipment performance and overall maintenance efficiency
- Helpful integrations with ERP, SCADA/PLC, and other essential systems
eMaint includes it all, along with full-service CSV validation (eMaint CSV) designed for heavily regulated environments. This ensures your CMMS:
- Integrates all necessary departments and stakeholders, from IT to product quality control teams
- Meets regulatory requirements and is audit-ready from implementation onward
- Adheres to best practices beyond basic regulations (such as ISPE’s GAMP guide)
- Preserves the quality and safety of your products and data
- Leverages time-saving automations to improve compliance while reducing manual office work
- Produces accurate, helpful, and compliant reports and audit trails
Our eMaint CSV team delivers functional requirement assessments, electronic record and signature compliance review, and operational qualification test scripts for comprehensive validation and revalidation. So, you get an audit-ready CMMS you can rely on in real-world conditions and a trusted team to support you along the way.
Validating your CMMS isn’t optional. But struggling with it is. Try a free eMaint demo to learn how we can help.