Data integrity aspects of reporting results for the specification parameter related and degradation products in chromatography data system

The most convenient way to implement the requirements of Good Manufacturing Practice and the data integrity principles in a control analytical laboratory is to automate the entire analytical process as fully as possible. Obtaining a final reliable result from an analytical testing as part of a formal analysis is one segment of the process of providing Good Manufacturing Practice. In this paper, we describe the steps by which one control analytical laboratory can formalize and automate the entire process of obtaining and issuing analytical results through creating Report Template for calculation of the specification parameter Related and Degradation Products as part of a Chromatography Data System. The process is described in several steps from designing and structuring of the report so that it would respond best to the end-user's requirements, through identifying eventual oversights in the creation phase, to the final phase of validation, which once again confirms the integrity of its content and justifies its use for formal analysis. The use of such validated Report Templates for calculation and reporting of the results from analytical testing eliminates the human error factor and increases the confidence in the issued results as well as in the entire laboratory’s workflow. Their application facilitate compliance with regulations and minimizes manual input of data which in turn meets one of the most crucial requirements of Good Manufacturing Practice.Keywords: data integrity, chromatography data system, report template, related and degradation products