FDA

New 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 Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals JDSupra Business Advisor published an article discussing an overview of…

Mesa Monitoring

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 own unique set of needs and requirements. Having each department follow exactly the same set of specifications and/or standard operating procedures will likely not be an optimal…

ViewPoint

Have 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 adding on to an existing hardwire system as a direct replacement for the AS-Connect for the AmegaView hardwired system, or offers new clients a powerful solution…

Dr. Sandle

Dr. 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 controls range from efficient cleanroom design to implementing gowning procedures. A full, detailed article on what you can do at your facility to maintain workplace safety and prevent contamination is available…

Compliance

What 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 be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…