FDA audit war rooms are now antiquated and old-school for companies with modern quality systems. Do not discount the credibility that openness and transparency brings to an audit.
Many think the war room during an FDA audit is standard practice; the war room is for “organizing quality documents and staging employees for meeting with the auditor”. Unfortunately, war rooms only stall auditors and decrease company effectiveness.
Here are 2 reasons why FDA audit war rooms are becoming less popular:
- You are going to show them [auditor] the record no matter what.
Why? Because they asked for it.
- You can’t change anything about the quality record – that’s illegal.
Let’s face it, your documents are either complete and accurate or they are not. No amount of fancy manila folders or color-coordinated paper-clips will impress the auditor into ignoring compliance. Its better to have a manufacturing quality and traceability system in place that enables you to have confidence that every record meets your standards.
Now I am not saying you should be answering questions not asked by auditor. If they ask you a question, answer that question, nothing more, nothing less. Be concise.
One significant observation the inspector will make is the turnaround time of completed requests. With manual quality systems that are largely paper based, the war room was the method to achieve this response time.
Automated manufacturing quality and traceability systems bring all of the documents within fingertips, and have ensured completeness at the time of the original entry and approval. You can instantly and accurately retrieve any requested record in real-time having confidence that your electronic record is retrievable and already vetted by automated verifications.
Do not discount the credibility that openness and transparency brings to an audit. Especially when that openness and transparency is powered by a system that gives you confidence in your quality.
Don’t make your auditors wait. Who likes waiting? Be responsive to them be helpful to them. And take them out to long meals. 🙂
Good things to have quick access too that may be outside of your electronic batch record system:
- A quality system manual and/or site master plan
- An organization chart showing the relationship of quality and regulatory management
- Key SOPs that manage your quality and compliance system: CAPA, record control, internal audits, change control, process flow diagrams