Surviving an FDA audit is like trial by fire for many organizations. Even the most meticulous organizations have the potential for being nitpicked by the FDA for the smallest noncompliance.
The FDA has devised the Bioresearch Monitoring Program, or BIMO, an on-site inspections and data audit programs, designed to monitor all aspects of the conduct and reporting of FDA-regulated research.
How to survive an FDA audit largely depends on how well the organization implements the requirements of the BIMO. BIMO is quite comprehensive, as it monitors Sponsors or Contract Research Organizations (CROs)/Monitors, the Institutional Review Boards (IRBs), Clinical Investigators (CIs) and nonclinical laboratories.
BIMO Program Objectives
Basically, surviving an FDA audit is dependent on how well it understands and implements the provisions of BIMO. The core objectives of the BIMO Program are:
- Protect the safety, rights, and welfare of human research subjects; and
- Assuring the integrity, reliability and quality of data collected.
The BIMO’s functions
If organizations have to survive an FDA audit; they need to understand the BIMO Program’s functions:
- Auditing clinical data
- Inspecting ongoing clinical research
- Inspecting nonclinical laboratories and IRBs
- Educating, training, and implementing FDA’s Application Integrity Policy.
Understanding factors that trigger an inspection
Another key to surviving an FDA audit is to understand the factors that prompt an inspection of research. These could be any of all of these:
- New product or indication
- Any new technology
- History of non-compliance, and
- Even routine surveillance.
So, any organization that has to survive an FDA audit has to be aware of the intricacies of this program. Following and implementing its requirements step-by-step acts as a checklist for ensuring that it stays compliant.