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Services Team for Computerized System Validation
Project duration: 1 year, 9 months
Brief description
Setup of an independent service team for Computerized System Validation (CSV), which consists of various specialists for ongoing projects and releases, focusing on CRM systems, complaint management system, data warehouse, user administration and interfaces to external systems.
Supplement
The following tasks are performed in detail: Creating, reviewing and/or approving system lifecycle artefacts/documents. Distribution of the CSV approaches to project members, system owner and process owner. Support of quality assurance to optimize the approach. Identification of documents and activities needed or impacted by projects, enhancements, changes for GxP computerized systems. Driving and coordinating of all validation relevant activities in CSV lifecycle phases (Implementation, Maintenance and Support, Retirement) aligned with project planning. Timely detection of deviations from validation approach with resulting communication with project members and system responsible persons. Escalation to IT Quality Assurance Regular status meeting and Jour fixe with IT Quality Assurance.
Subject description
Validation means the objective proof that the special requirements for the specified intended use of a GxP Computerized System can be permanently fulfilled. These systems are used worldwide to support medical diagnostic equipment. The functional risk assessment by those responsible for business and compliance is the technical benchmark for the scope of the concrete validation activities. Based on the intended use of the system, the regulatory chapters of 21 CFR (U.S. law) are applicable. Similar regulations exist for the European Union and at country level. Communication in the project is in English (oral and written). The Validation Service Team cooperates with other international teams.
Overview
- Industries pharmaceutical industry
- Specialist tasks servicing, Shared Services, team organization, validation
- DV tasks IT consulting
- System environment Business Intelligence, Service-Oriented Architecture (SOA), standard software: CRM systems
- Procedure model Scrum
- Standard software JIRA, Salesforce Tracker
Project period02.07.2018 - 31.03.2020
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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