If you have been in a business that the FDA regulates, then you know something about the various regulations and the 21 CFR Part 11 in particular. This particular regulation focuses on businesses that have to do with the life sciences. It governs the application and use of data gathered because the consequences can greatly affect the consumers. Should software malfunction when one is using a medical device, or if a drug is poorly tested, then serious harm can be done to the patient. The FDA came up with this regulation in order to make sure that such incidences are avoided.
What is this regulation?
This regulation has been put in place to provide organizations with guidelines that must be adhered to when working with data and other applications. If the company will be collecting data and reporting it, they must adhere to the said guidelines in order to ensure the integrity of all the data collected. This ensures that the products are of the highest quality, and should there be any defective ones, they are quickly identified and taken care of in a responsible manner.
Compliance
The following environments must comply with this regulation:
- Units that carry out clinical testing – Particularly those that manage the data from clinical trials
- Manufacturing plants – Those that record data on quality and product development
- Laboratories – Particularly those that provide test results on any kind of material
As long as the organization or business is in the life sciences and manufacture healthcare products or food for sale, they must comply with this regulations.
Ensuring Compliance
There are very many models out there but if you are looking for software that is compliant, then your best bet is Salesforce 21 CFR Part 11. This law was instituted in the year 1997 but unfortunately, many people find it difficult to comply with it. Salesforce can help you stay compliant because they have taken the guesswork out of it. You will find that the application is simple and helps you control the information in your database. If you are looking to build your own applications, they will be compliant if you use the Salesforce Platform.
If you are non-compliant, you may incur very heavy penalties or have your organization shut down. It is therefore important to realize that it is mandatory to comply with the regulations set by the FDA. From time to time, the FDA will conduct an inspection to make sure that you understand the regulations and are compliant.
Anyone who is genuinely concerned for his or her business will ensure that they remain compliant because of what could be at risk. However, you need to choose the manner in which you want to implement the regulations. If you go with the manual way of doing it, get ready to make sure that you document every step of the process either manually or electronically. There should be handwritten sign-offs to everything as well.
To make things easier, it is a better idea to work with the Salesforce application which will help you monitor every step of the process, give you control of the lifecycle and the final delivery.
Autho Bio:
Lucy Jones is a renowned IT expert. Be believes Flosum.com can help you manage the life cycle of data collection and delivery while remaining compliant with FDA regulations. Not complying can cost you the business so it’s better not to take the risk.