Is your Vision Inspection System Audit-Ready?

If not, you could be getting a “483” or facing possible fines, even a plant shutdown!

"A "483" is what the FDA issues when a pharmaceutical company or any FDA regulated industry is found to be negligent in some facet of their operations. Severe fines or a plant shutdown could accompany this. 483's could be for violations of cGMP, for non-validated processes, and, increasingly, for violations of 21 CFR Part 11. Companies choosing to use electronic records and electronic signatures should ensure that they meet part 11 rules to avoid a 483 warning letter."

	WARNING CERTIFIED MAIL RETURN RECEIPT REQUESTED "You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties".

What are the implications of an FDA 483 Letter?

• The FDA 483 is a legal document, and inspection observations could be construed as deviations from the GMPs. These GMP violations can be used as counts against you in legal proceedings.
• The FDA 483 is part of the company's history. If future problems arise, past FDA 483s could be caused to enhance legal actions against you.
• The FDA 483 is available via the Freedom of Information Act so the competition could get a copy and use it against you in the market. All FDA 483 letters are available on the FDA’s Web Site.

Optel Vision, 21 CFR Part 11 Ready Systems

Optel Vision system’s design provides full compliance control features for today’s regulated customer. The key components of a 21 CFR Ready system include:

• User Management Tools
• Data Security
• Audit Trail
• Traceability
• Batch Data Collection
• Production Statistics

Optel Vision proactively provides comprehensive support and service to assist regulated customers comply to 21 CFR Part 11. This regulation addresses all regulated electronic record systems. It is focused on product safety and traceability.