3 Tips For Maintaining Compliance
To help your facility maintain compliance, we have put together 3 tips and tricks that cover key information you need to know.
First, it is crucial to understand the three commonly used types of validation protocols for your systems and equipment:
  1. Installation Qualification (IQ)
  2. Operational Qualification (OQ)
  3. Performance Qualification (PQ)
In some cases, the IQ and OQ protocols can be combined together into what is commonly referred to as an Installation and Operational Qualification (IOQ) protocol. Please visit us at mesavalidation.com for more information on validation protocols.

Second, we need to know what to look for when it comes to Calibration Certification and Regulation Requirements. Here are key features you want to look for in a validation partner in order to achieve compliance:
  1. ISO 17025 Compliance Calibration Certification
  2. 21 CFR Part 11 Compliance
  3. NIST-traceability
Finally, you want to make sure you understand the services you can receive from your validation partner to ensure that your equipment, systems and processes are working properly. These services should include:
  • IQ/OQ/PQ Protocol Generation to meet the cGMP, ISO, FDA, and EC requirements of your operation.
  • Protocol Execution to ensure that all execution is done correctly and adheres to cGMP practices, assuring your regulatory compliance.
  • Final Report Generation to accurately document the results of the protocol execution.
  • Deviation and CAPA investigation and resolution.
  • Good Documentation Practices are observed during all phases of the Qualification or Validation.
Mesa Labs is proud to offer all of these services, and more. For further information on how to maintain compliance, please contact a Mesa expert at mesavalidation.com.

Reaching Full Potential with a CM System - Certified Training
Written by James O’Malley, Senior Director of Monitoring Sales

Knowing how to properly use, view and maintain your Continuous Monitoring System (CMS) is an essential part of compliance. Making sure that your personnel have the proper training is an important part of your Standard Operating Procedures (SOPs) and requires diligence in making sure that they are up to date on report setup, programming inputs and most commonly used features that are available on your system.

We always recommend setting up a demo system on a different PC/server than your validated system for the training of new personnel or refreshers for existing personnel. When your system is due for service, Preventative Maintenance (PM) calibration or during expansion it is always a great idea to let your CMS service representative know that you would like some training on your system to go over any changes accompanying your new software update and just a general refresher training from the manufacture.

The FDA, AABB, Joint Commission and other organizations all require that your personnel have the proper training to use the system. This training should include:

  • How to handle alarm events
  • How to properly document events for regulatory compliance
  • Which reports require daily, weekly or monthly review
  • How to select reports in the system for historical review of collected data
After training is complete, a certificate or signed completion of training document is recommended as part of your validation documentation. With support from you CMS provider, all users on your system will be properly trained and certified to meet your SOPs and regulatory environment requirements.

For more information, please contact a Mesa Monitoring expert today.


How To Contact Mesa Monitoring
Please visit us at monitoring.mesalabs.com, or choose from the following suggested points of contact:
General Inquiries and Purchase Orders /
Inside Sales and Admin
303-565-2724
monitoring@mesalabs.com
Service Agreements /
Service Contract Administrator – TJ Crane
303-565-2724 Ext. 10437
tcrane@mesalabs.com
Parts and On-Site Service Quotations Territory Sales Representative
monitoringsales@mesalabs.com
Technical Support 303-565-2724, Dial 4

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