Any business that has to do with life sciences and life sciences related testing should be familiar with the Title 21 CFR Part 11 of the FDA or the Part 11, as we commonly call it. This legislation directly impacts all companies. It requires companies to not only comply with a particular code of ethics and laws, but it also requires acute data maintenance on the part of these laboratories, companies, and corporations.
You need to be aware of Part 11 especially if you belong to any four of the following categories –
- Laboratory: if you supply test results on any materials.
- Clinical testing units: if you manage clinical trial data.
- Manufacturing units: who deal with product development and quality.
- Food business: if you are an organization or life science business that sells food and healthcare products.
The 21 CFR Part 11 is a critical legislation that is changing the face of the life sciences business.
What’s the role of technology in FDA regulation compliance?
The changing face of technology makes it even more challenging for organizations to unify their data and ensure that they remain in sync with this legislation. Salesforce is helping these companies develop applications and software programs to consolidate relevant data. However, it is of prime importance to stay in touch with your Part 11 regulations and laws, while building the applications so your users can remain compliant as well.
What happens if you fail to comply?
Most businesses fear the loss of revenue. However, this is not the case with Part 11. If you fail to comply, you may have to pay hefty penalties to the government. That is why any applications built using the Salesforce platform needs to know the rules and outline them for their (industrial) users. Too many non-compliance grievances can even lead to the FDA shutting the business down. What can be more reason to comply with the 21 CFR Part 11?
The Flosum and Salesforce duet at your rescue
Flosum along with Salesforce Dx can create and manage tools for such industries that always need to stay on top of changing legislations and codes of ethics for life sciences organizations. No one wants to face the hassle of human rights and animal rights organizations. That is another key driver behind the Salesforce 21 CFR part 11 guided application development that caters to life sciences based organizations dealing with routine experimentation, manufacturing and production of healthcare products. The aim is to build a cohesive efficiency across the entire development pipeline.
Salesforce Dx is the first choice for all developers in 2017. The new developmental platform has made building specific applications for quality control, and ethics control so much easier for both the builders and the clients.
Author Bio:
Lucy Jones is a software analyst. She has been working with Flosum.com for years. It has been her platform of choice long before Salesforce Dx made its presence felt in the tech world. She is the leading man behind a number of leading lifestyle apps of the day.
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