How Safety for Compounding is Changing
Exposure to pharmaceuticals in compounding environments can lead to a number of health risks for pharmaceutical employees and patients. These health risks can range from contact with hazardous waste...
View Article12 Keys to Successfully Implementing a Continuous Monitoring System
If the installation and implementation of a Continuous Monitoring (CM) system is on your project radar, then there is a lot of work to be completed. Although the project may initially appear to be...
View ArticleHow Do I Fix the “No Sensor Contact” Alarm? (Video)
If you are getting the “No Sensor Contact” alarm for your CheckPoint G4 Sensor, there are a few simple steps you may take to troubleshoot and resolve the issue. The video below will help guide you...
View ArticleKeys: Assemble a Dedicated Project Management Team
One of the most important factors to successfully implementing a Continuous Monitoring system is to assemble a dedicated project management team that can stay together for the entire duration of the...
View ArticleWhat is Validation?
There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should...
View ArticleMesa Labs Announces New Suite of Validation Services
Mesa Labs is pleased to announce the addition of a new suite of validation services and the launch of the new website www.mesavalidation.com. Utilizing products such as Mesa’s Biological Indicators and...
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Keys: Compile a Complete Equipment List by Department
Compiling an accurate and complete Equipment List is a supporting key to a successful project. “Gargabe In, Garbage Out” is not just an adage. Investing the time, effort, and resources to accurately...
View ArticleDr. Sandle on Cleanrooms & Contamination
For pharmaceutical manufacturers, hospitals and other facilities that contain cleanroom technology, the risk of contamination can be avoided by implementing proper environmental controls. These...
View ArticleHave You Seen the New VP Connect?
With more power, more capacity, and larger expansion capabilities, the new ViewPoint (VP) Connect is the perfect upgrade or facility enhancement. The VP Connect allows existing clients to continue...
View ArticleKeys to Successfully Implementing a Continuous Monitoring System
Keys: Understanding Unique Needs There is no such thing as “One Size Fits All” when it comes to implementing a Continuous Monitoring (CM) system. Each department within an organization will have its...
View ArticleHow to Protect Customers from Foodborne Illness
According to the U.S. Centers for Disease Control and Prevention, about one in six Americans gets a foodborne illness each year. Foodborne illnesses cost the U.S. economy billions each year, and the...
View ArticleKeys: Secure Department-Level Commitment
Each department will have its own set of quality standards and operating requirements, and it’s important to secure the Department Director’s commitment to assign department-level system owners to...
View ArticleFDA Code of Federal Regulations Title 21, Section 820.70
Proper Production and Process Controls are critical to ensuring that a medical device conforms to its established specifications. These controls are used to define where deviations from the device...
View ArticleNew FDA Food Safety Modernization Act (FSMA) Rules Published
The U.S. Food and Drug Administration (FDA) has made two final Food Safety Modernization Act (FSMA) rules public: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive...
View ArticleFDA Code of Federal Regulations Title 21, Section 820.75
Section 820.75 of the FDA Code of Federal Regulations Title 21 defines the Process Validation requirements of 21CFR820.70 – Production and Process Controls. The Process Validation requirements include:...
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Keys: Annotated Floor Plans
Vital to the overall success of the project, a complete set of annotated floor plans for monitored appliances and points is important to have for the design, implementation and validation stages of...
View ArticleWebinar: Process Validation Within the Quality System
Mesa Labs recently hosted a Webinar on Process Validation within the Quality System. We are now happy to provide the recording of the entire 45-minute informational presentation, led by our DataTrace...
View ArticleFriday Facts – Device History Record
The FDA requires manufacturers to maintain Device History Records (DHR). Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the...
View ArticleMesa Monitoring CMS Used at Children’s Hospital of Aurora
The Children’s Hospital of Aurora Colorado is one of the top-ranked pediatric hospitals in the United States. They were founded in 1908 in Denver, Colorado and have been helping heal sick children for...
View ArticleFriday Facts – FDA Inspections
If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem....
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