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Celia Brown02/20/202 min read

10 Tips for Audit Preparation for Emerging Life Sciences Companies

Whether it’s your first audit or your five hundredth, you can never be too prepared. That's why ZenQMS invited quality and systems expert Ed Morris, managing partner at The Morris Group, to host a webinar and offer his tips for preparing for an audit.  

Above all, Morris recommends that clients approach audits with confidence and organization, not dread. He encourages businesses to focus on the spirit of the law vs. the letter of the law. “Auditors are NOT expecting perfection. What they really want to see is if you have a Quality Culture in place and if you are working continuously to improve upon it.” 

Below are some of the audit preparation tips Ed Morris shared during the webinar - and a link to the full presentation as well:

  1. Don’t be arrogant. You won't help yourself or your organization if you enter the audit with an attitude, bragging about your ‘clean bill of health’ to date. This might invite further scrutiny. Instead, be confident, but cordial. 
  2. Request a scope of the audit and an agenda in advance. It's unlikely that the FDA will provide much detail in advance, but those performing vendor qualification audits will be ready and willing to provide what you're looking for, including a list of requested documents. 
  3. Build a library of documents in advance of the audit. If you have an eQMS, you can easily set up a training program for the auditors and load it with the documents that they have  requested. 
  4. Designate the members of your audit team in advance. Experts recommend including one executive, one or two Quality specialists, and a technical person who can answer questions about supply chain, systems, etc. 
  5. Assign one person to serve as the “Speaker”. For the duration of the audit, the speaker should be the only one answering questions. No one else should speak unless the speaker directs a question to them.
  6. Stick to the question. It’s important to answer their question and then STOP TALKING. Embellishing to provide further clarity often results in revealing something that could be detrimental.  
  7. Relax! Auditors are people and they are professionals. Be friendly and establish a human connection of some kind with them upon arrival but don't go overboard. 
  8. Prepare a good lunch and snacks for the auditors. You don’t want hungry/ cranky auditors. If they end up in a bit of a food coma, that may be beneficial to your team. 
  9. Spoon feed documents to the auditors. Provide specific documents when requested to do so. Don't overwhelm them with a huge document dump at the outset of the audit. 
  10. Ensure that your IT staff is trained in GxP and 21 CFR Part 11. Additionally, you'll need to have a disaster recovery system in place, including RTO/ RPO metrics. Your disaster recovery plan should be tested annually at minimum.

Watch the full webinar on-demand now>>


Celia Brown

Celia Brown is the Vice President, Sales and Marketing at ZenQMS.