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Service Task Management with Jira
Project duration: 1 year, 8 months
Brief description
Introduction of JIRA in order to maintain tasks for computer system validation (csv) with Scrum board for weekly sprint. Benefits: Validation activities become transparent for stakeholders. They become schedulable and evaluable. After initial configuration of JIRA by PTA, members of Validation Unit (= PTA stuff) use it for the System Validation Service for the client. JIRA platform is maintained by the client and can be used for projects.
Supplement
For each new release of a validated system, csv tasks have to be repeated in order to keep the validation status of the system. Maintain tasks in Jira allows the Validation Unit to visualize the completeness of documentation and the distribution of work to team members. Each employee can recognize by the task assigned to him who the stakeholders are, what is specifically required, where he can find appropriate instructions (SOPs, work instructions) and where he can book his work.
Subject description
The wide-ranging CSV activities for validated systems used by the client are transferred to a service team, supplied by PTA. First, current and further tasks are collected and entered in the JIRA backlog. Tasks are assigned to various projects (release-related) and systems (6-8) which were validated on a GxP basis within the framework of the FDA and the Medical Devices Act. For each new active sprint, tasks are transferred from JIRA-Backlog into the sprint, so that they became visible on the Scrum board. Multiple tasks can be assigned to each member of the Validation Unit. Theses tasks, which are always documented in the same form, shows who are stakeholders, affected project and system as well as what is specifically required. Users can access corresponding instructions (SOPs, work instructions) and the cost center to debit.
Overview
- Industries pharmaceutical industry
- Specialist tasks FDA validation, GxP/GMP, IT service management, QM in the project, Shared Services, Total Quality Management
- DV tasks IT consulting
- System environment Business Intelligence, standard software: CRM systems
- Procedure model Scrum
- Standard software JIRA
Project period02.07.2018 - 29.02.2020
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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