Quality Management System (QMS) Update in a Regulated Environment
Loading...
Authors
Author (Corporation)
Publication date
2023
Typ of student thesis
Bachelor
Course of study
Collections
Type
11 - Student thesis
Editors
Editor (Corporation)
Supervisor
Parent work
Special issue
DOI of the original publication
Link
Series
Series number
Volume
Issue / Number
Pages / Duration
Patent number
Publisher / Publishing institution
Hochschule für Wirtschaft FHNW
Place of publication / Event location
Basel
Edition
Version
Programming language
Assignee
Practice partner / Client
Neurostatus-UHB AG, Basel
Abstract
The company XYZ discussed in the study, develops software for clinical research on Multiple Sclerosis (MS). Yet, their QMS (containing SOPs and other important quality documents) implemented in 2020 is out of date and misaligned with current best practices, posing compliance and performance risks. Some of its defined processes are not followed, leading to an oversight of responsibilities, including maintaining the QMS. In light of emergent challenges, this inadequacy highlights the need for an immediate QMS update.
Keywords
Subject (DDC)
Event
Exhibition start date
Exhibition end date
Conference start date
Conference end date
Date of the last check
ISBN
ISSN
Language
English
Created during FHNW affiliation
Yes
Strategic action fields FHNW
Publication status
Review
Open access category
License
Citation
Njuguna, S. (2023). Quality Management System (QMS) Update in a Regulated Environment [Hochschule für Wirtschaft FHNW]. https://irf.fhnw.ch/handle/11654/42163