Form 483 Audit Management Software

Never receive an FDA Form 483. Use MasterControl audit software to keep your processes and documentation under control.

Using a well-defined audit management software system will put you on the right track to regulatory compliance. A digital system will manage the large amount of documentation that is necessary to maintain an audit-ready state and mitigate the chance of receiving of an FDA 483 letter. Improve data integrity, improve process and procedure documentation, and ensure training is always up to date with MasterControl audit management software.

Free Resources

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Frequently Asked Questions About FDA 483 Audit

What is a 483 audit?

A Form 483 is a letter that is issued after an FDA inspection outlining any observations where the conditions, a process, or documentation is out of compliance or in violation of a regulation. The FDA 483 letter will state the citation as well as the specific conditions observed during the audit.

What happens when you get a 483 letter?

At the end of an audit, all Form 483s are discussed with the company to ensure a solid understanding of the issues and why they were deemed out of compliance. Companies have an opportunity to respond to the observations within 15 days and communicate corrective action/preventive action (CAPA) before further enforcement.

What is the most common FDA 483 inspection observation?

The most common reasons for an FDA Form 483 can vary from year to year, but the more common compliance issues can include: data integrity issues; insufficient documentation; lack of documented process; lack of training; or insufficient cleaning and maintenance. Audit management software will help companies keep track of all documentation and stay in compliance.

How do I pass an FDA audit?

Know the regulations, laws, and governance that apply to your product. Implement a quality management system (QMS) and strictly follow all regulations. Using a digital QMS with an audit management solution can help companies manage all of the documentation necessary to remain compliant. Use your audit management software to complete internal audits as well, which can highlight areas of improvement before a formal FDA inspection.

Free FDA 483 Audit Software Resources

Free resources to help you find audit software and avoid an FDA 483.

Industry Brief: Compliance Audits: 4 Solutions to Avoid Failure
White Paper: Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments White Paper: How to Successfully Complete an FDA Inspection
Free Templates: Basic Policy SOP Template (Word Document)

MasterControl 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.