Avoid an FDA Form 483

Get a digitized audit management system.

Most companies would rather avoid receiving an FDA Form 483 after a visit from the U.S. Food and Drug Administration (FDA). The best way to avoid an FDA 483 is a comprehensive audit management system that connects every part of the quality system and keeps you in an audit-ready state.

Learn how MasterControl can help you:

With FDA 483s, audits, and inspections.
Connect documents, training, audits, and QEM.
Avoid future FDA 483s and audit findings.

MasterControl Form 483 Audit Management

When it comes to compliance , audit management software helps life sciences companies pass inspections from the FDA and other regulatory bodies.

Avoid data integrity issues.

Data integrity issues are more likely to happen in paper-based environments. MasterControl eliminates many of those issues and provides complete audit trails to help you pass any inspection.
Always have the needed documentation.

An FDA Form 483 can easily result if a company can’t readily provide the most recent version of a document to an inspector. MasterControl keeps everything in a centralized location so you can easily search for and retrieve needed documents.
Keep employees current on training.

Employee training is essential in a regulated environment. However, keeping track of training and ensuring employees are up to date on changes is hard. MasterControl provides training matrices so you can see at a glance which employees are fully trained. The system also automatically tracks who needs to be trained on what and sends out training tasks whenever there’s a change.
Integrated with other quality processes.

MasterControl lets you maintain all of your quality processes on the same system, eliminating errors that come from manually transcribing data. Documents, training, audit, and quality events are all connected and can exchange information.
Track the aftermath of your inspection.

If you do receive a Form 483, your next step should be eliminating the issues that led to observations. MasterControl lets you initiate and track all quality events and corrective actions so you can find the root cause and avoid further problems during future inspections.