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If your organization produces foods, drugs, biologics, cosmetics, medical devices, radiation-emitting electronic products, veterinary products, and/or tobacco products, it will need to comply with the United States Food and Drug Administration’s stringent regulations.
But as with most of these large regulatory bodies, the rules the FDA implements are subject to change, and keeping abreast of the latest developments can be a challenge. One area in particular where many organizations fall short is documentation. Documents can go missing, be destroyed (deliberately or accidentally), or simply contain errors that mean your organization is not fulfilling its FDA compliance obligations.
The good news is that there is a way your organization’s documents can pass FDA compliance checks seamlessly and with little input from you. Keep reading to find out how.
Why FDA Compliance Matters
The FDA has developed stringent regulations to ensure that companies implement strict quality management processes and procedures which afford higher quality products. Failure to comply can result in serious consequences.
First and foremost, there are potential FDA enforcement penalties that can be imposed for non-compliance. As the FDA outlines, “misdemeanor fines under the [Federal Food, Drug, and Cosmetic] Act may reach $500,000 under some circumstances.”
Your organization could also lose its import rights if it falls foul of FDA regulations, meaning you potentially stand to lose a significant proportion of your revenue.
Then, there is the reputational damage that can occur. Will your customers remain loyal if your organization has been found to be in breach of FDA regulations? Will your shareholders still have confidence? And what will the impact be on your hard-working employees?
You need to keep detailed, long-term records documenting your processes, procedures, and products as part of complying with FDA regulations. While you may or may not be required to submit these for scrutiny on a regular basis, you need the peace of mind that they are available and accurate should you be asked to do so.
However, these complex documents usually contain information from multiple business systems, in various native formats. Compiling this information into a single, standard document that meets regulatory requirements is tedious, time intensive, and prone to error.
So what’s the answer?
How You Can Stay Compliant With Ease
At Seal Systems, we specialize in Enterprise Output Solutions and can act as FDA compliance consultants. We can implement an automated, streamlined process that takes care of all your important documents for you.
Our automatic file processing solution takes the required information from your various business systems, converts it from a native language into a standard format, and then creates a PDF/A with all the necessary information. Security elements including stamps and watermarks and digital signatures are also captured and included in the final document. A title and table of contents, as well as additional metadata, are also added before the document is released.
The end result is a standardized, organized, secure and traceable document that meets FDA regulatory requirements. Seal Systems can then securely distribute it as necessary.
With this process automated, your documents are less prone to errors and contain all the required information, freeing up one of your staff to work on other, potentially value-add areas of your business.
Take Your First Step To FDA Documentary Compliance Freedom
SEAL Systems has been helping organizations automate the distribution, security, and compliance of their valuable documents for over 30 years. Our out-of-the-box solutions are designed to work with multiple ERP and PLM systems, including SAP and Teamcenter, for faster implementation.