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 system implementation. Here are examples of how and when floor plans are utilized: System Design – During the design phase of the project,…
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: Validation of the production process is required if the final results of a process cannot be verified by subsequent inspection or testing. The validation testing and results,…
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…
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 specifications could occur as a result of the manufacturing process. Section 820.70 of the FDA Code of Federal Regulations Title 21 defines the Production and Process…
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 oversee both the initial implementation and the on-going support of the system. The primary goal of the system owners is to ensure the system is initially set…
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 impacts can be disastrous for a business’s future. Outbreaks can break the ties the business has built with their customers, deteriorate brand loyalty…
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…
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…
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…
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 and completely capture all vital information will lead to enormous tangible net value. Each of the following fields taken from Figure 1…