How FDA Part 11 Can Help Your Research

As research scientists we are always looking for better ways to keep our data and research notes secure and accessible to our colleagues. Lab notebooks, publications, and PhD theses are crucial components of accurate data keeping in research labs. But these may not always be the best tools for collaboration and research.

Online notebooks and data sharing apps make it easier than ever to record and find old data. Data sharing also becomes easier with a good online app. But these all have a common weakness and that is data security and availability. Digital data theft and computer system malfunction are just two of many reasons why researchers should carefully think about how and where their data is stored digitally. Fortunately, with the advent of new technologies and cybersecurity standards there is no reason to compromise data security for convenience and better collaboration.

In the United Stated, the Food and Drug Administration (FDA) has a published a set of regulations to ensure digital data integrity, security and accessibility for the healthcare industry. This set of regulations that govern digitally stored data is known as Title 21 CFR Part 11. Companies that are regulated by the FDA like medical device manufactures are required to adhere to this set of regulations. This ensures that digitally stored data are not vulnerable to fraud and data loss.

While it is not necessary for non-FDA regulated research labs like academic labs to follow the Part 11 regulations, this set of regulations offer a standard that can bring peace of mind to researchers who store their data online or on their computers. Part 11 regulations lay out an extensive set of requirements that must be met by a software application. Some of these requirements may be necessary for specific healthcare industries where traceability and accountability to the federal government may be important. But a subset of the Part 11 regulations describe how a digital platform must ensure data integrity and security. Since data security is an important concern for all researchers who store their data digitally, Part 11 compliance can be a beneficial feature of any platform that is used for computerized lab data management.

In summary, if you store your research data and notes online or on your computer the FDA Part 11 regulations can help you secure your digital documents, prevent fraud, and collaborate easier. Your lab may not be required to strictly follow these guidelines but using software that adheres to Part 11 and other privacy standards can give you peace of mind.

LabLog rigorously follows a number of standards including the Title 21 Part 11 regulations and the EU-U.S. and Swiss-U.S. Privacy Shield Frameworks. Learn more by booking a demo today: