When it comes to auditing, being prepared is more than half the battle.
You don't always know when your next audit is coming, but by understanding what auditors will look for and having everything in order, you and your team can approach any audit with confidence.
Our latest whitepaper focuses on how to structure your study for audit readiness from Day 1.
It discusses how inspectors conduct audits through the FDA Bioresearch Monitoring Program (BIMO) and includes a "study guide" with key areas that will help you prepare.
It also outlines the four main concepts of audit readiness and how you can apply them. Here's a short overview.
The Four Main Concepts Of Audit Readiness
1. Know the Study
Having a deep understanding of your study is the best thing you can do to prepare for an audit. That includes:
- Knowing the ins and outs of your study protocol
- Knowing the study subjects
- Knowing protocol deviations and adverse events
- Knowing study records and study logs
- Understanding the IRB's expectations
2. Principal Investigator Engagement
Your principal investigator can set the tone for how your study operates. They can help you ensure audit readiness by attending required training, being available to monitors during visits, being an active leader and setting a high bar for compliance.
3. FDA Inspection Day Plan
Sites and sponsors can be proactive by thinking through the logistics of an audit. That includes:
- Establishing an inspection standard operating procedure (SOP)
- Identifying a designated location
- Determining internal inspection roles
- Practicing for inspection day
4. Avoiding The Tendency To Over-Prepare
While you always want to be audit-ready, you don't want to take unnecessary steps to prepare that can introduce errors. One example is rewriting adverse event sheets to make them easier to read. Although the intention is good, the approach can actually make things worse if it eliminates original data or adds errors.
How IMARC Can Help You Ensure Audit Readiness
Although taking these four steps will go a long way to help you be audit ready, enlisting an objective third party to review your sites and data before the FDA does will give you additional confidence you are prepared to pass.
As a global medical device CRO, IMARC has more than 20 years of experience conducting clinical research audits. In addition to helping your team prepare for a BIMO inspection, we can conduct site GCP audits, vendor qualification audits and sponsor/CRO audits.
Our team can even conduct remote audits through a secure, compliant file-sharing platform. This can help your team ensure audit readiness in a more convenient, cost-effective manner.
To learn more about our auditing services, contact us today.