You Can Trust the Result
We use an FDA compliant Outside of Specification (OOS) process to investigate all OOS test results before they are reported.
Before we notify you of an OOS result, we perform an internal review of anything DYNALABS might have done to contribute to the OOS result. This review includes:
- validating sample preparation and testing processes, and
- thoroughly investigating calculations, reagents, instruments, and personnel training.
Only after we have confirmed an OOS result is valid, will you be informed.
You Can Find Out What Happened – Just Ask
We are glad to work with you to find out what caused the OOS result and determine how to prevent it in the future.
Our collaborative approach relies on your cooperation to review formulas, results history, batch records, equipment/training records and anything else that might have contributed to the failure.
We will use our expert knowledge of OOS investigations, sample preparation, and testing to help you:
- recognize issues,
- discover solutions,
- implement those solutions to prevent similar OOS results in the future, and
- run additional tests to ensure the implemented solutions perform as expected.
Still Have Questions? Come Visit Us
DYNALABS is pleased to host you for a Quality Systems audit. Please contact your Sales Representative, if you would like to visit our facility. We ask only that you give us at least 30 days of notice.
DYNALABS is dedicated to providing solutions, not just results, and we have the certifications and reputation to back it up:
- FDA registered
- Quality systems meeting cGMP (Current Good Manufacturing Practices) Regulations
- ISO 17025 and 9001:2008 certified
- DEA Licensed
- Bureau of Narcotics and Dangerous Drugs Licensed in Missouri
- Protected by U.S. Patent Numbers 7,197,405 and 7,660,678