Use ERP Software to Help with an FDA Audit

Jan 12, 2018 4:29:00 AM

The FDA’s Food Safety Modernization Act (FSMA) aims to ensure the safety of the U.S. food supply by shifting the FDA’s focus from responding to contamination to preventing it, and food and beverage manufacturers should have spent the past few years preparing to respond to an FDA inspection. Inspections can come with no notice, and FDA investigators expect you to be prepared with documentation demonstrating your use of good manufacturing processes (GMP) and overall food safety.

If you’re struggling to prepare (or just haven’t), you can ease the process by using a modern ERP system to adhere to FSMA guidelines and make FDA audits painless.

What Information Does the FDA Require?

According to the FDA Inspection Checklist published by the Food Industry Counsel, the FDA’s number one enforcement priority is “to carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements.”

The FDA has established three information requirements food and beverage companies must have to be compliant:

  • Finalized, written food safety systems
  • Ensured ease of access to company records
  • Appropriately documented corrective actions

Here’s how to use ERP software to help with an FDA audit.

ERP and Your Written Food Safety Systems

The FDA requires proof of written and finalized food safety systems. Moreover, they require you to have primary and secondary ‘designated individuals’ (DIs) who are familiar with all the elements therein.

These documents include a wide range of content, including:how to use ERP software to help with an FDA audit

  • GMPs
  • Sanitation programs
  • Plans for preventive control
  • Recalls
  • Environmental monitoring
  • Foreign supplier verification
  • Sanitary transportation
  • Food defense
  • Produce safety

To ensure the proper documentation exists in finalized form, you need the document version control and workflow approvals inherent in ERP. In addition, because your DIs must be knowledgeable about all aspects of the system, you need real-time updates regarding their training status; to ensure continuous learning, modern ERP enables you to model processes so that each time a new plan element is loaded to ERP, automated workflows require designated individuals to review and verify knowledge of the new information. You can even establish time-based parameters so automated alerts inform upper management when primary or secondary DIs have failed to keep up to date with training.

Easy Access to Records in ERP

FDA investigators require fast and easy access to the supporting records for each of the programs and plans you have in place. They also expect the records to remain organized and maintained to allow for immediate retrieval in the event of an audit ─ including surprise audits – for a minimum of two years.

Capturing Corrective Actions in ERP

If your company responds to a deviation outside food safety parameters, you must document your corrective actions and be prepared to present them to FDA investigators – so your designated individuals need to:

  • Find data indicating the root cause of the deviation
  • Document how you identified it
  • Indicate the actions you took to prevent recurrence
  • Offer an empirically supported written conclusion that the deviation poses no threat to food safety

Modern ERP allows you to model specific processes in the system to perform end-to-end corrective action management, so not only can you model the process necessary to react properly when a deviation occurs, you can model the process for documenting and sharing corrective actions.

Never Sweat an FDA Audit Again

Modern ERPs prove invaluable when preparing your company for an FDA audit, not only from an information management perspective but also from a process perspective. The ability to set strict parameters and processes for managing and reporting on your food safety measures virtually forces your company to be prepared to enforce food safety, its measurement, and its reporting.

To learn more about using an ERP to keep you compliant with the FDA's FSMA, contact us today.


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