Signed into law by President Obama in January of 2011, the Food Safety Modernization Act (FSMA) is an FDA reform meant to set new standards for food supply safety for a new generation. The FDA calls the act “the most sweeping reform of our food safety laws in more than 70 years,” and its main purpose is the prevention of food contamination. Unlike previous legislation, the FSMA focuses not only on responding to contamination after it has already happened, but on preventing it from happening in the first place. With that said, the FSMA also seeks to improve industry-response processes after contamination has occurred.
The Document Management and Control Side of FSMA Compliance
As with any “sweeping” piece of legislation, the FSMA is an act with many different facets. As such, food processors or other food industry companies should visit the FDA website if they are looking for guidance on how to become compliant with the FSMA. However, if your company is in need of help to reach compliance with the FSMA’s document control and management standards, then you have come to the right place.
Document management and control are huge components of the FSMA, with an entire section of the act, Section 204: “Enhancing Tracking and Tracing of Food and Recordkeeping,” devoted to improving the overall documentation processes observed in the food industry. By itself, Section 204 is complex, and you should read the full text of the FSMA at the link above if you haven’t in the past.
In general, though, the goal of the FSMA’s document control and recordkeeping measures is to make it easier for food plants, farms, and other industry suppliers to track where they have sent food. Better tracking helps the FDA mitigate the effects of food contamination. The new recordkeeping standards also require food plants to highlight foods that are particularly susceptible to contamination, specify where in the food production process contamination is most likely to occur, and more. Grocery stores and other vendors are also required to track where the food on their shelves came from.
The bottom line is that Section 204 calls on food growers, producers, handlers, and vendors to adopt document control and management systems that fulfill the following criteria:
(A) develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;
(B) develop and demonstrate appropriate technologies, including technologies existing on the date of enactment of this Act, that enhance the tracking and tracing of food.
A Note on Oversight and Compliance
In addition to implementing new standards for recordkeeping among companies involved in the food supply chain, the Food Safety Modernization Act also gives the FDA greater authority to demand access to company records. If the FDA believes that your company could be somehow linked to a dangerous instance of food contamination, then they have the authority to access and copy your files. As such, your records must be available at a “central or reasonably accessible location” and must be available to the FDA “not later than 24 hours” after they are requested.
By giving the FDA greater authority to access the records of food producers, suppliers, and vendors, the FSMA seeks to give the government a better chance of uncovering compliance issues or contamination incidents in the industry. As such, it also makes good recordkeeping more important in the food supply industry than it used to be. Failure to provide the FDA with request records in a timely fashion, or failure to present records that are compliant with the FSMA, can result in anything from litigation and fines to suspension of your facility’s FDA registration.
Using eFileCabinet as Your Document Management System
An advanced document management system such as eFileCabinet can help your business meet the recordkeeping standards necessary to become FSMA compliant. Used by a wide range of businesses in a slew of different industries, eFileCabinet is a useful tool for digitizing your filing system, creating more efficient pathways for document access, and locking down your company’s information with high-tech virtual security.
First off, eFileCabinet could be hugely helpful to a food supplier trying to determine where a certain supply of food was sent. With intuitive document indexing and a full-text feature that makes searching and finding documents a breeze, eFileCabinet allows users to find the files and folders they need quickly. With just a few keystrokes, you can locate the file that would have taken hours to find if it were tucked into a filing cabinet somewhere.
eFileCabinet is also useful from a security standpoint. Among food supply companies, one of the biggest concerns about FSMA has been the FDA’s ability to demand a company’s files. In addition to containing information about the tracking and tracing of foods, such files might also contain trade secrets and other confidential information. By allowing an outside entity access to their files, food supply companies justifiably worry that their files might fall into the wrong hands.
Many security features with eFileCabinet can help to assuage those fears. For instance, the program is outfitted with 256-bit encryption, which protects your files whether they are in transit (being sent to an FDA representative for review) or at rest (stored on our servers). We store all files redundantly across numerous secure data centers and do frequent backups so that you don’t have to worry about lost documents.
Finally, eFileCabinet works on role-based securities, which allow you to ensure that only certain individuals have the authorization to access certain files. So, if the FDA asks to see your files, you can simply give a government representative the authorization they need to access your records right in the eFileCabinet system. Thanks to role-based security, the FDA will be able to view your files, but no one else will.
At eFileCabinet, we take confidentiality and security very seriously. Our program doesn’t necessarily offer automatic compliance with FSMA, and you will have to review the legislation to make sure you are meeting the FDA’s requirements on document control and management. However, since eFileCabinet is compliant with other government branches and standards—including the SEC, FINRA, and HIPAA—you can rest assured that our document management system is a strong foundation for ensuring that your company is FSMA compliant.
Interested in learning more about eFileCabinet? Visit our website at www.efilecabinet.com to request a 15-minute demo.