How Does TraceableLIVE Support 21 CFR Part 11 Compliance?

By Ayisha Malik, EMEA

Traceable® digital data logger temperature monitoring instruments with TraceableLIVE® technology can help you be compliant.

Long before the advent of Google, Amazon, Facebook or even smartphones, in 1997, the US Food and Drug Administration (FDA) recognised the inevitable movement towards the use of electronic data and issued 21 CFR Part 11. These rules provide a framework for FDA-regulated companies to guarantee security and compliance when working with electronic records.

Today, use of the internet is commonplace in every facet of our lives; both the storage and transfer of electronic information and instantaneous communication have become the norm. Therefore, every successful FDA-regulated life science business not only has to make sure they remain compliant with the changing rules and regulation but maintain a high level of efficiency. Using electronic records and communication benefit both these objectives.

TraceableLIVE can help you be compliant with 21 CFR Part 11 when you are using Traceable digital data loggers to monitor the temperatures of your samples, vaccines, or other valuable items during storage or transport.

What is 21 CFR Part 11?

The Code of Federal Regulations (CFR) outlines rules and regulations published by the federal government of the USA; divided into 50 titles, it represents broad areas of federal regulation. Title 21 codifies the rules that govern food and drugs within US borders for the FDA, the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP) and Part 11 is the section that sets forth the guidelines for using electronic documents and signatures. At a high level, the law is there to make sure that that life science companies implement good business practices by defining the criteria under which electronic records and signatures would be considered accurate, authentic, trustworthy, reliable, and confidential. It does not mandate the use of electronic systems but allows for traditionally used paper records and handwritten signatures to be replaced by electronic ones in line with Good Manufacturing Practice (CGMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations.

Critical requirements of 21 CFR Part 11 and how TraceableLIVE supports your needs

Validation – Under 21 CFR Part 11, “Validation of systems [need] to ensure accuracy, reliability, [and] consistent intended performance.” This means you, as a business, are tasked with formally defining how the elements of your system are supposed to work, develop scripts and tests to validate the process. This can be rather tedious; therefore, using a compliant software, such as TraceableLIVE®, would alleviate your worries and provide reassurance on data security and audit logs in the relevant areas.

Record keeping – 21 CFR Part 11 stipulates that your system has an indexing and search functionality, for quick and easy retrieval of information. TraceableLIVE® stores and itemises data logs in an intuitive and easy-to-use format, making it simple for both the user and inspector to quickly find important reports.

Audit trails – the law mandates the “Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.” TraceableLIVE ensures your data logs are appropriately documented, linked to specific devices or individuals, and associated with an automatically generated audit history that is impervious to modifications. This means, the temperature reports generated by TraceableLIVE are automatically produced and protected from unauthorised alterations.

Security controls – Under the 21 CFR Part 11 law, entry into your systems need to be controlled by unique login and password for every user. TraceableLIVE® Premium subscription allows you to provide your team members with their own log-in details, making sure every process is tracked back to the responsible individual.

Training – Part 11 dictates that all system users have the necessary training to perform their assigned tasks. TraceableLIVE offers an intuitive and easy to use platform, making any training simple and effective.

What is TraceableLIVE?

TraceableLIVE is a cloud-based platform that leverages IoT technology to offer round-the-clock monitoring of your critical environments. Compatible data loggers use Wi-Fi or Ethernet connections to allow remote monitoring of your samples and reagents, whether you are in the next room, next building or on the other side of the globe. TraceableLIVE®- capable products can send out real-time push notification if anything goes wrong; remotely view data logging history, effortlessly generate reports, and control alarm parameters.

To set up your account, download the TraceableLIVE App on your tablet or smartphone or on your PC via traceablelive.com. Add a device to your account and start monitoring. The Premium account is 21 CFR Part 11 compliant; everyone on your team can receive email, text, and push notifications on the environments you monitor, improving your chances to quickly resolve any temperature excursions that might occur. Basic subscriptions (no 21 CFR Part 11 compliance) and Free subscriptions (limited storage & accessibility) are also available.

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