![]() Who likes waiting? Be responsive to them be helpful to them. Especially when that openness and transparency is powered by a system that gives you confidence in your quality.ĭon’t make your auditors wait. 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 verification.ĭo not discount the credibility that openness and transparency brings to an audit. With manual quality systems that are largely paper based, the war room was the method to achieve this response time.Īutomated 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. One significant observation the inspector will make is the turnaround time of completed requests. If they ask you a question, answer that question, nothing more, nothing less. Now I am not saying you should be answering questions not asked by auditor. Its better to have a manufacturing quality and traceability system in place that enables you to have confidence that every record meets your standards. No amount of fancy manila folders or color-coordinated paper-clips will impress the auditor into ignoring compliance. 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. Let’s face it, your documents are either complete and accurate or they are not. You can’t change anything about the quality record – that’s illegal.You are going to show them the record no matter what.Here are 2 reasons why FDA audit war rooms are becoming less popular: Unfortunately, war rooms only stall auditors and decrease company effectiveness. 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”. Do not discount the credibility that openness and transparency brings to an audit. FDA audit war rooms are now antiquated and old-school for companies with modern quality systems. ![]()
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