Over the last few years the Food and Drug Administration (FDA) has become progressively more aggressive and tactful in the way they conduct their audits. More often than not, companies are unprepared to manage an FDA inspection or to effectively respond to observations. Because of this, tackling an FDA audit can be a stressful and laborious experience. However, one thing is certain - a little prep work can go a long way. This article will discuss five specific ways your company can prepare for an FDA audit to make the process run smoother and ensure your company is prepared.
1) Document Your Standard Operating Procedures (SOPs)
Having a clear, well-defined set of standard operating procedures is crucial for every company. To make the audit process easier, these SOPs should align with the regulations the FDA requires of your industry and should always be documented in one central location. This way when an audit does become necessary, your team can put together a custom-built, Policy & Procedure Manual that pulls all SOP documents into a single binder to be handed to an auditor. This Policy & Procedure Manual will also provide other pertinent information beyond just your company’s SOPs. For example, printing an overlay with details (Author, Approver, Current Date, Version, Revision History etc.) will make it easy for an auditor to quickly gain an overall understanding of your procedures, while they can also drill down into a particular SOP if needed.
2) Thoroughly Train Your Employees
In addition to focusing on the SOP and document control aspects in preparation for an FDA inspection, you should also be sure to train your employees in all pertinent company policies and procedures. No one looks forward to an FDA inspection, but as long your team is knowledgeable and prepared, they can understand what is expected of them at each stage of the process.
The first thing your training procedure should incorporate is simulated FDA examinations. Use this prep time as an opportunity to coach employees on what to say and how to interact with an auditor. You can even reach out to professional contacts who you know have already been through an FDA inspection and ask them to evaluate your readiness. Your preparation should go through every aspect of what could happen during an FDA inspection: from the moment an FDA auditor enters your office, to where to hold the inspection, to the specific roles and responsibilities of each team member.
Even further, it is crucial to regularly review the standards that manage your company and ensure there are none that need to be updated. If a revision is required, update employee training concurrently and hold occasional training sessions to refresh the skills of your team. When dealing with an FDA audit, it is important to prevent complacency from overtaking your processes and to demonstrate your on-going commitment to quality to the auditor.
3) Conduct Regular Internal Audits
Internal audits are a great way to not only prepare for an FDA inspection but also ensure your company’s processes are meeting your quality standards and that you comply with any and all relevant laws and regulations. The overarching goal of an internal audit is to ensure that your company’s policies and procedures are followed and to alert you of any holes in policy compliance so that they can be resolved before they cause more serious problems.
When looking for a third-party audit service provider, or when putting together your own internal auditing program, make sure that the process will be much tougher than the audit you will experience during an FDA inspection. This will ensure that when the FDA audit rolls around, your team will understand exactly what to expect and can feel relaxed knowing all of your business processes are thorough and compliant.4) Have Quality Management Practices in Place
Having thorough quality management practices in place is critical when preparing for an FDA audit. When being audited, it is essential that your company can demonstrate how you operate within government regulations. With a quality management system, employees can assign, track, and verify action items, set up training requirements, and automate workflows to ensure that non-compliance issues are eliminated
Quality management empowers decision makers to track who oversees a document, where it is in its lifecycle, who has accessed a document, who has printed it, and who is responsible for maintaining and seeing it to its conclusion. It can also help to guarantee that the highest quality business processes are followed to ensure you’re meeting the needs of customers, stakeholders and FDA requirements. Your entire quality management system can be implemented through the system to quickly and easily prove FDA compliance every step of the way.5) Use a Document Control Software to Manage Your Processes Electronically
By maintaining complete digital records of your processes in a document control software, you demonstrate your company’s commitment to quality and accuracy. With your documents and product data in a secured electronic repository, you can respond to an auditor’s request for any document or record at a moment’s notice. Make sure to implement a proven system for electronic data and document management to maintain data integrity.
The use of a document control system also gives your company the advantage of version control. During an audit, it is very likely that there may be a need to show appropriate review procedures of draft documents. Therefore, it is important that review signatures and comments be paired to the document they are related to. It is not enough to just have a record of what is happening within your company; you must provide regulatory authorities with accurate, legible, original, consistent, and attributable records upon request.
This complex process requires a formal version control system within the organization. If an auditor or inspector is not provided with traceable actions, test, and resolutions of errors and deviations, validation status is often looked at as suspect. So, in order to meet regulations and remain compliant in the eyes of these authorities, you need an electronic document control process that includes version control capabilities.
How Can ENSUR Help?
FDA audits can be time-consuming and stressful for your whole team. Luckily, using a Document Management Software like ENSUR can help you tackle this process painlessly. With our document control and quality management features, you can organize all of your company’s documentation digitally – this includes standard operating procedures and all employee training material. So, when your company is facing an inspection, all of your important information is right at your fingertips.
Request a demo today to find out more about how ENSUR can make the FDA audit process easier for your company.