The FDA has strict requirements and high expectations surrounding audits.

Their protocols are in place for a reason, so here are some tips to help your team prepare, manage, and pass the inspections. When the right technology and people are in place to ensure compliance, inspections are less stressful and more successful. To feel perfectly prepared and confident about meeting the FDA’s QSR requirements, keep reading…

Prepare Your People

Because the FDA will interview your team members, including subject matter experts, management, and lower level employees, it is important that everyone is prepared for questions and can provide consistent information to the inspectors. To equip your team, consider conducting mock audits, which cover frequently asked questions. It is also essential that your team meets FDA standards and that each member is qualified for the jobs that he or she is performing. It may be necessary to provide team members with additional training if you identify gaps, and that training must be appropriately documented.

Prepare Your Procedures

To pass an inspection, procedures must adhere to the FDA QSR regulations. Reviewing procedures regularly and verifying correct execution will put you at ease. A few common requirements include documented instructions and obeying standard operating procedures. Walking through processes can ensure they are tested, validated, and controlled. If there are areas for improvement, update process documentation accordingly after giving out clear instructions.

Keep Track of Complaints

When quality standards are questioned by customers, it is essential that a complaint file is created, saved, and delivered to the relevant people. These records must be thorough enough to avoid additional questioning and need to be handled and documented in the correct way. The procedures around the complaint must be reviewed and correct measures must be taken for resolution. Often, the FDA will spend time understanding all complaints, the procedures in place, and any necessary follow-up actions—documentation makes this process as smooth as possible.  

Because there are a lot of documents, procedures, and people that need to be prepped for an audit, the right tools must be in place to make information accessible. Using a mobile data collection app enables you to streamline operational processes and ensure compliance measures are met. With flexible technology, your team is also able to easily understand their duties and processes to meet compliance, and documents can be readily available for audit preparation and FDA QSR inspections. Additionally, efficient content distribution helps address complaints and quality-related threats in a timely manner. What you need to know is this: An enterprise field management solution—customized to your business—will enable your organization to prepare, manage, and pass the FDA’s QSR audit.

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