When it comes to complying with federal regulations on your manufacturing facility, it's incredibly important to be aware of the big picture in order to meet every requirement and avoid any possible violations or punishments. One such regulation many small business owners may not be aware of is 21 CFR Part 11, also known as the FDA's current good manufacturing practice in manufacturing, packing, or holding of drugs; better known as 21 CFR SCADA. These regulation details requirements that need to be met when manufacturing and handling pharmaceutical drugs, including those produced in sterile environments such as clean rooms.
Understanding SCADA
Each food facility is unique. The type of foods it manufactures produces or stores will impact how it must be designed and managed. Some processes are considered low-risk, while others can pose serious threats to public health and safety if not handled properly. In general, food facilities fall into one of three categories: low-, moderate-, or high-risk. Each category impacts how a facility must be designed and managed in order to minimize risk factors.
21 CFR SCADA for the pharmaceutical industry
21 CFR Part 11 is an FDA regulation that establishes requirements for electronic records, electronic signatures, and audit trails for certain types of computerized systems. These systems are those that include computerized medical devices such as control systems used in manufacturing facilities and laboratories. Pharmaceutical companies are highly regulated by 21 CFR Part 11 and must comply with 21 CFR Parts 210 and 211 in addition to 21 CFR Part 11. The Food and Drug Administration's (FDA) regulation on current good manufacturing practice (CGMP) requires pharmaceutical companies to develop an adequate system of controls over all aspects of their products. This includes anything associated with producing, processing, packing, storing or holding a drug product.
21 CFR SCADA for automotive factories
Many of today's cars have a 21 CFR SCADA system (Supervisory Control and Data Acquisition) that provides remote access via cellular/wireless. At its core, a 21 CFR SCADA system is any system with Remote Access Capability (RAC) through a secure shell or command-line interface, providing logging capabilities and other advanced features. Because of their high level of security, it's difficult for these systems to be accessed by individuals other than an authorized user or administrator. There are many industrial applications that use RAC in order to facilitate remote operations—and some even require RAC in order to work at all.
21 CFR SCADA for Energy Generation Plants
DOE wrote a memorandum (known as a SCADA rule) that requires energy generation plants, such as coal- and nuclear-fired power plants, oil refineries and chemical manufacturing facilities, to develop a comprehensive emergency response plan in case of an accident. In 2014, DOE held workshops across several states to address safety concerns related to 21 CFR Part 11 and explain how those concerns relate to emergency response. Part 11 is one of six federal regulations requiring electronic records for pharmaceutical companies; others are for electronic medical records, electronic funds transfer at retail point-of-sale locations, air transportation reservations and remote identification of firearms. The workshops were part of DOE's effort to create an industry standard for handling emergency situations without endangering lives or creating more harm in case of an accident.
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