Maintenance professionals play a critical role in driving Good Manufacturing Practice (GMP) compliance for organizations in the life sciences. A validated computerized maintenance management system (CMMS) is a key tool in this process, helping teams maintain assets and facilities to maximize product safety, purity, and effectiveness.
Learn what “validated CMMS” means in the context of GMP, why it matters, and how you can easily ensure CMMS validation. We’ll also explain the three stages of validation: installation qualification (IQ); operational qualification (OQ); and performance qualification (PQ).
What Is a Validated CMMS for Pharmaceutical Manufacturing?
A validated CMMS has been installed, configured, and rigorously tested to ensure that it performs according to GMP specifications.
Organizations subject to GMP guidelines are required to meticulously track and document every inspection, calibration, and preventive maintenance task. A validated Computerized Maintenance Management System (CMMS) makes that process easy, optimizing safety and reliability while providing audit trail compliance.
In the United States, the Food and Drug Administration (FDA) stipulates certain practices for the use of digital tools like CMMS. Those practices are detailed in Title 21 of the Code of Federal Regulations (21 CFR) part 11. If your organization uses CMMS for maintenance record keeping, you need to comply with 21 CFR, and that includes validating your CMMS.
Who Is Responsible for CMMS Validation?
Just about every organization subject to FDA regulations, like pharmaceutical companies, food and drink manufacturers, and medical device manufacturers, must validate any software that is used to track and document maintenance processes for GMP compliance.
You (not the software manufacturer) are responsible for validating your own CMMS so that it meets your unique compliance requirements. However, your CMMS vendor should be equipped to help with every stage of the CMMS validation process as well as troubleshooting.
You are required to re-validate your CMMS whenever major changes take place, like:
- Switching to a new CMMS
- Upgrading to a new version of your existing CMMS, especially when there are changes to the core functionality
- Changing the scope of your CMMS deployment
- Making major changes to your IT infrastructure, i.e. changing servers or operating systems
How Do You Validate a CMMS?
Validating CMMS software means following a series of steps to ensure the data collected by your CMMS is accurate, reliable, and protected from tampering. During the validation process, you rigorously test your CMMS to check its performance.
During validation, you also configure your system’s access and permissions so that only authorized employees can access databases, update information, and sign maintenance records.
CMMS validation is a three-part process. The three stages are known as Installation Qualification (IQ); Operational Qualification (OQ); and Performance Qualification (PQ).
Understanding the Three Stages of CMMS Validation: IQ, OQ, and PQ
Here’s what the phases of CMMS validation look like. Note this isn’t a comprehensive list of processes, but an overview.
Installation Qualification (IQ)
Installation qualification is the first foundational step to validating your CMMS software. At this stage, you need to verify and document that the software is correctly installed and configured.
During the IQ stage, you also need to ensure that you have the appropriate infrastructure so your CMMS can run correctly. That means verifying that your servers have sufficient processing power, memory, and storage, and putting backup systems in place.
Operational Qualification (OQ)
During the operational qualification stage, perform a series of tests to check whether the CMMS functions correctly. (OQ is sometimes called functional testing.)
Check the software’s data collection and storage capabilities, ensuring that your CMMS correctly stores data entered manually, streamed from sensors, and inputted from other platforms. Check to see that your data access and permissions are working correctly.
You’ll also need to check all CMMS alarm and notification functions. For example, if you’ve set it to trigger an alert when the temperature reaches a certain level, conduct testing to see how that alert performs both at and near the threshold.
Performance Qualification (PQ)
During the performance qualification stage, you continue testing your CMMS, with an emphasis on reliability and consistency.
This time, you’ll test it in real-world conditions, mimicking the conditions in your plant as closely as possible. The goal is to see how the CMMS performs during peak load times and how it handles high data and query volumes.
At this point, it’s also a good idea to check your backup, recovery, and redundancy systems to see how they function under stress. If your plant has any unusual features or workflows, this is the time to see how your CMMS handles them.
Working With the Experts To Streamline the CMMS Validation Process
Validating your CMMS can be a long, overwhelming process. But the outcome is worth the effort: a validated CMMS drives better maintenance practices, so you can produce reliable, safe, and effective products, all while improving your compliance outcomes.
Because validation is so complex, it’s a good idea to partner with a team of experts who can speed up the process and help you whenever you need to re-validate the software. The result is streamlined, efficient validation, and a CMMS you can rely on to help keep your organization compliant.