Attention medical device manufacturers! 5 tips for passing your FDA audit with flying colors

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No matter how well you’ve organized your documents, procedures and data in preparation for your first regulatory audit—it never hurts to make sure you’re in top shape before the auditor walks in the door, especially when future business viability is on the line.

To help you face your next FDA audit with confidence, we pulled together our top 5 tips for ensuring a successful audit. Enjoy!

 5 tips for passing your next FDA audit

1.  Document your standard operating procedures (SOPs)—to a degree 

Without recording every specific detail of a given procedure, make sure you capture overall requirements for all your key business procedures. This allows you to prove that you ‘do what you say’ as a company and maintain up-to-date SOPs that are in sync with processes. But don’t get so detailed that you may be found in noncompliance with what you say you do. Ask your team to help you review your procedures at regular intervals and make sure to tweak where necessary.  

2.  Train your team

You may have very thorough regulatory standards in place for your business, but how confident are you that your team adheres to them? Spend time brushing up on important regulatory standards with your team before your audit and maintain training records for each employee so that an auditor will know your staff is well trained and your employee training program is up-to-date.

3.  Embrace technology

Today, it’s vital that you control, track and mange your data electronically. By keeping digital records of documents like design history files (DHF), bill of materials (BOMs) and SOPs, you can quickly locate a document or record requested by an auditor and be confident that your data is organized and secure. Not to mention, having your records stored digitally instead of in manila folders demonstrates a high level of accuracy and thoroughness.  

4.  Audit yourself

Third-party auditors can shed tremendous light on how you can improve your processes and prepare for your audit. Not only do they bring a fresh, objective opinion to the table, but they also help your employees understand what to expect during a formal audit.

And when third-party auditors make recommendations, be sure to listen and empower your team to follow through with real change.

5.  Always have proof

Maintain accurate and complete product history files with information like SOPs, BOMs, authorizations, reports, reviews and notes so that no auditor will doubt your company’s tight control over its procedures and processes.

And if you don’t have a document that the auditor requested, be forthright. By evading an auditor’s request, you’re creating a negative impression of your business in the auditor’s mind and poking holes in your credibility. Honesty is always the best policy.

How did you prepare for your most recent audit? 

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About the Author

Alyssa Sittig
Alyssa played an instrumental role in the development of the Arena Blog and social media channels from 2011 to 2012. Joining the team with a background in public policy, Alyssa ... Read More 

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