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Complaint handling for a laboratory information system

Project duration: 5 years, 5 months

Brief description

The main task of the project is to process customer complaints for a laboratory system used on the international market and in a strictly-regulated environment. The problems are forwarded to the employee detail analysis after an initial analysis by the global customer service. As well as the analysis and speedy determination of the cause, documentation and communication of the cause and solution proposals play an important role. Documentation of customer complaints must meet the regulations and quality standard of a strictly-regulated environment.


Main tasks: – Speedy analysis of customer complaints and quickest possible determination of the cause. – Documentation of the cause and of solution proposals according to the regulations and quality standards of a strictly-regulated environment. – Creation of ICATTs in ClearQuest to provide software developers with the analysis and cause of the program. – Creation of CAPAs in SAP for critical problem causes. – Cooperation with global customer service in order to solve the customer complaints as quickly as possible according to the specifications of a strictly-regulated environment. – Risk analysis and evaluation of the product risk. – Representation and communication of the results in the project meetings.

Subject description

TThe laboratory information system of the customer uses an Oracle-based database. The communication interfaces use the standardized protocols ASTM and HL7, as well as other proprietary protocols. The drivers used for the interface to the analysis devices in the laboratory are written mainly in C++. The customer complaints and problems are documented in CM Clarify. The complaint-related behavior is analyzed by reproducing it with the corresponding software version and performed at program code level. The PL/SQL developer, as well as Team Foundation Server (TFS), Visual Studio 2010 and MKS Integrity Client are used. Documentation of the error is maintained as an ICATT in IBM Rational Clear Quest and made available for the developers. With the analysis of the product risk, a decision is made as to whether it is necessary to create a CAPA in SAP and which corrective and preventive measures can be taken.


Project period01.01.2008 - 31.05.2013

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