The Importance of Quality Management
There are always going to be changes that occur with any business, so it is important to make sure that you are keeping up with those changes successfully. This is especially true if you are working in an industry that is regulated by governmental agencies, such as the FDA. You need to make sure that you have the right type of quality management system in place in order to remain compliant with the existing regulatory requirements as well as any new requirements that may come into play. For example, if you operate a laboratory, it may be necessary for the data that you work with to be regulated under the FDA 21 CFR (Source: FDA 21 CFR by Mystic Management). What are some of the things that you can do to make sure that you are in good shape when it comes to 21 CFR part 11 compliance?
One of the things that you can do is to make sure that you are running software which is updated for that purpose. Many of the old software programs did not handle the raw data in a way that would have made it within compliance. This can make it difficult for you to continue to remain in compliance, which can cause some obvious problems. Any type of electronic data practice that you use should be approved by the FDA in order to remain in compliance. Of course, there are other regulatory agencies that may impact your industry as well, and you would want to ensure that any documentation that you regularly produce is going to be in compliance with those agencies. Updating the software that you use regularly can often help you to keep in compliance.