One of the biggest FDA HOT BUTTONS is how a firm handles out of specification (OOS) lab results. Lab errors should be rare, and with this system, they will be.

Just one OOS investigation will cost more than the price of this product. Using this system, it is estimated that at least 95% of all OOS results will be eliminated, and those that do occur, will generally be explainable.

Order today and eliminate or greatly reduce regulatory exposure due to laboratory error.

Save thousands of dollars in investigative costs and unwanted negative regulatory exposure.

Avoid unnecessary Warning Letters and 483 Observations.

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4-Step system includes:

>Identification and explanation of dozens of lab techinque deficiencies.

>Training and testing of analysts to identify and correct personal lab skill deficiencies.

>OOS results - what they are and what they're not. This critical section can help avoid a large percentage of OOS results.

>Chromatography practices designed to prevent most OOS results.

>Sample SOPs for Basic Labs Skills procedures and optimum chromatography practices.

> AND, an HPLC run flowchart for elimination of most if not all OOS results due to laboratory error