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Inquiry and complaint management for an internationally-operating laboratory information system
Projektdauer: 1 Jahr, 1 Monat
Kurzbeschreibung
The incoming customer inquiries and complaints are processed for a laboratory information system that has been on the market for some years. This is done with defined time limits and according to the regulations and ISO quality guidelines in the medically-regulated environment. As well as the procurement of all required information and the actual problem analysis, the employee is mainly responsible for cause determination and creation of a self-explanatory documentation based on the corresponding customer specifications. Special attention should be paid to the documentation regarding compliance, as all documents are subject to recurring audits from the relevant authorities.
Ergänzung
Main tasks: - Documentation of all required and existing information on the existing problem with the customer as well as communication with fields staff and with the customer. - Timely analysis and determination of the cause of global customer queries and complaints that are documented in CRM Clarify according to the requirements of a strictly-regulated environment. - Self-explanatory documentation of the analysis and cause according to the regulations and quality standards of a strictly-regulated environment. - Representation and communication of the results in the project meetings - Documentation of the errors in the HP Quality Center. - Risk analysis and evaluation of the product risk. - Creation of CAPAs in SAP for critical problem causes and triggering of corresponding corrective or preventive measures. - Communication and representation of critical customer complaints with the quality management. - Improvement of product documentation with information from the individual analyses.
Fachbeschreibung
The 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 queries, 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 in HP Quality Center 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.
IT-Projektdaten
- Branchen Pharma-Industrie
- Fachaufgaben closing, complaint management, complaints processing, Compliance, laboratory systems, quality management
- DV-Aufgaben Support
- Systemumgebungen Client/Server
- Vorgehensmodell customer standard
- Datenbanken Oracle Database
- Entwicklungs- und Testtool Crystal Reports, HP Quality Center, MS Team Foundation Server TFS, MS Visual Studio, PL/SQL-Developer
- Standardsoftware und BI Clarify
- Systemsoftware MKS Source Integrity
Projektzeitraum01.06.2013 - 30.06.2014
Kunden, die uns vertrauen
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