Truth Enforcer’s Compliance with US Food and Drug Administration (FDA)

The quantity of electronic records produced by businesses is set to increase across countries and industries. With this, regulations improve their frameworks to accommodate and manage these market changes. 21 CFR Part 11 (The Code of Federal Regulations, Title 21, Part 11) targets electronic records‘ authenticity, integrity, and confidentiality. This part of the code establishes precise and demanding requirements to support the increasing number of records without losing the three mentioned qualities.

The entity that will regulate and enforce the requirements is the US Food and Drug Administration (FDA). They will approach the organizations inquiring about how the controls to mitigate risks and uphold public safety are deployed while maintaining clear metrics of failure and success.

21 CFR Part 11: regulated industries and records

FDA-regulated industries can be anything from drug and pharmaceutical companies to biotech and food manufacturers. It encompasses a broad spectrum of entities involved in pharmaceutical and biotechnology operations. The framework 21 CFR Part 11 governs the regulations of such organizations. Furthermore, Subpart B of this framework is solely dedicated to Electronic Records and goes deeper into (§ 11.30) Controls for open systems, where it states:

“Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.”

Source: National Archives – Code of Federal Regulations.

If data is stored and/or transmitted in unrestricted environments, the risk of being tampered with increases. These risks can go from individuals having unauthorized access to accidentally changing information. Either way, more access typically translates to more liability. Deploying mechanisms within open systems is how you can control your environment and align with regulatory compliance, both of which will protect your organization.

System Controls for Compliance

What we exposed is just a key part of the 21 CFR Part 11, but it goes beyond this and into a broad range of non-compliance liabilities that must be tackled with conviction. If the liabilities are ignored, then the consequences will come. Failure to comply as an individual, a manager, and a company will result in FDA warnings and monetary fines or escalate to suspension of operations or criminal charges.

That is why Truth Enforcer tackles the company’s challenges in ensuring document authenticity, maintaining data integrity, enabling traceability, and simplifying the verification process.
The simplicity of the verification process is the primary goal, and blockchain technology is the method. The solution provides an intuitive interface that can be integrated with current workflows. You gain the ability to verify document authenticity and validate integrity without resource-draining investigations or analysis.

We can keep and, in some cases, enhance operational efficiency when detecting unauthorized changes while providing an immutable audit trail.

The operational efficiency that detects unauthorized changes also comes with an immutable audit trail. This trail is a chronological record of all the actions that may affect the document’s integrity. Unalterable records with user identification and timestamping will allow your enterprise to enhance accountability and traceability.

You can start to see that the key benefits of Truth Enforcer go beyond software or innovation. This is about demonstrating compliance with regulatory requirements by providing a clear history and transparent record that facilitates audits and/or investigations, in other words, a tool that empowers enterprises.

By addressing the concerns about integrating with existing systems, cost of implementation, and user adoption, Connecting Software helps businesses align with 21 CFR Part 11 and other data-driven regulations.

Protect your Enterprise and Maintain Compliance

The reality of this and other industries is that compliance is not optional. You and your enterprise understand that the explosive growth of data and records made regulations adapt and expand their action area to specific elements of your enterprise. This legal and regulatory tackling needs to be handled. Truth Enforcer allows you to ensure integrity by verifying authenticity while integrating seamlessly into your existing workflows. We also have the Truth Enforcer for Power Automate Connector if you want to create your workflows and incorporate them in parallel with other tools. The question here is to maintain compliance and integrity and let our solution boost your productivity and minimize costs by eliminating lengthy and complex verification processes.Stay ahead of potential disruptions – be proactive and become prepared. Reach out to us; let us help you connect your enterprise with the right software solutions.