Environmental monitoring software function and operating procedures for 21 CFR part 11 compliance

Regulatory changes.In the past 20 years, there have been several times with the computerized system application in GxP regulation about the application of changes.For the first time in 1997, the center of attention is the FDA chapter 21 CFR part 11.

Electronic records of regulatory focus on the latest shift from CSV (computer system validation) to CSA (guarantee) a computer system.These changes and their rules guide (e.g., part 11) is designed to help companies cope with the emergence of cloud computing, cloud computing allows users to use the Internet managed network to a remote server to processing, management, and store data.This latest changes reveals the record of use for mechanical equipment design strategy of risk inherent in the computerized system.

Despite the changes in the field of regulation of single event, but they are interrelated.All events are based on the existing GxP intersection between the focus and the changing technology.21 CFR part 11 reduced the risk of transition from paper records to electronic records.Good distribution specification change in the GDP of everyone associated with the product (from the processing of raw materials to the finished product distribution) are assigned the same obligations.Data integrity guidelines require us to record, communication and storage of data overall thinking.The computer system, focusing on the testing software and systems that to ensure the effectiveness and safety of product.As a result, the United States food and drug administration (fda) issued draft the new guidelines in 2020: "manufacturing, operations and quality guarantee system software of the computer software".

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