Abstract
Abstract. The importance of software validation increases since the need for high usability and suitability of software applications grows. In order to reduce costs and manage risk factors, more and more recommendations and rules have been established. In the field of pharmacy the vendors of so-called chromatography data systems (CDSs) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last few years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that wishes to create, edit and sign electronic information instead of printing them on paper. Subsection CFR 21 part 11.10(h) explains how to perform an input check for manual user entries as well as for data that will be collected from an external device. In this article we present an approach performing the double entry method on data provided by the hardware instrument in order to investigate possible influences on the raw data by the handling CDS. A software tool has been written which allows us to communicate with a high-performance liquid chromatography (HPLC) detector and acquire data from it. The communication is completely independent of a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as with the double entry method for the data verification. For the second CDS we checked whether it would be applicable after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software.
Highlights
High usability and suitability, risk management and data integrity are terms more and more users of software applications have to consider when they integrate them into their standard operating procedures
All experiments using the commercial chromatography data systems (CDSs) and Second Controller Instance resulted in chromatograms as shown in Fig. 3 or similar ones
The deviation of the signal given as the difference between the signal value of CDS OpenLab ChemStation® and the Second Controller Instance is plotted against time like in the default chromatogram (Fig. 3)
Summary
Risk management and data integrity are terms more and more users of software applications have to consider when they integrate them into their standard operating procedures. In the fields of medicine, pharmacy and the food industry any occurrence of risk to patients and customers leads to the usage of software applications whose developers established the principles of software validation in their software development life cycle. Following these guidelines helps to reduce long-term costs, failure rates and recalls (Center for Biologics Evaluation and Research Center for Devices and Radiological Health, 2002). Manufacturers and vendors of analytical instruments like high-performance liquid chromatography (HPLC) or gas chromatography (GC) systems are requested to implement several parts of the Code of Federal Regulations Title 21 (CRF 21) if they would like to create a validated chromatography data system (CDS) software package for their product. The CFR 21 deals with the environment of food and drugs (Office of the Federal Register and National Archives and Records Administration, 2017) HPLC and GC instruments are mainly used for.
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