Five Tips for Passing Your FDA Audit with Confidence

Passing a regulatory audit is the first priority of any manufacturer of medical devices. It can be an especially scary time for startup firms. All three medical device startups agree that if you take the time to organize your procedures, documents and data in clear, logical order, facing an audit doesn’t have to be so frightening. Here are their five tips to help you prepare for your next audit.

1. Document Your Standard Operating Procedures (SOPs)

Always “say what you do” in your SOPs. Capture the overall requirements of your procedures in sufficient detail to thoroughly document your activities. But do NOT record the specifics of every action within a given procedure — you will trap yourself. Too much detail in your SOPs makes it easy for an auditor to find you in noncompliance with what you say you do. Remember to solicit feedback from your staff regularly and to review and update your procedures often. Frequent reviews will keep your SOPs current and in sync with your processes as you fine-tune them over time.

2. Train Your People

Spend time and effort to thoroughly understand the regulatory standards that govern your business. Then, budget sufficient time and money to train your team so that they understand and comply with the regulatory standards completely. Establish and maintain complete training records for each employee to prove to an auditor that your staff is well trained and that they do what you say they do.

At regular intervals, review the regulatory standards that govern your business and revise and update employee training in response to changing standards as needs require. To prevent complacency from slowly creeping into your process and to demonstrate your on-going commitment to quality, hold occasional training sessions that refresh the skills of your employees.

3. Control, Track and Manage Your Data Electronically

By maintaining complete digital records of your processes, design history file (DHF), device master record (DMR) and bills of materials (BOMs), you demonstrate your commitment to quality, accuracy, and thoroughness. With your SOPs 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 control to maintain data integrity. Auditors will suspect the reliability and security of a home-grown data and document control system.

4. Audit Yourself

Empower your internal auditors to change processes, not just make recommendations. Keep senior management involved in process improvements and ensure that remedial actions happen on time and on schedule. Strengthen your internal auditing processes by hiring external, third-party auditors to perform vigorous mock audits. Not only will this provide you a fully objective analysis of your company’s performance and procedures, your staff will get real-life training in what to expect during a formal audit.

Remember that third-party auditors can have a wealth of experience that can help you improve your company’s processes in many ways beyond passing your audit. Make sure to solicit their input and suggestions for insights on how you can become a better organization.

5. Have the Proof at Your Fingertips

Do not try to evade an auditor’s request for a document or say that you have data you do not have. If you do not have what an auditor wants, admit it. Auditors believe evidence and not people. The faster you can produce evidence that satisfies your auditor, the better the impression he or she will have of your business.

Create complete product history files with all the documents and information — SOPs, BOMs, ECOs, authorizations, reports, reviews, and hurried notes — that prove to an auditor that you “do what you say.” Be able to access your data and documents quickly and easily to demonstrate that your company has tight control over its processes and procedures.