HR Management Systems in a GxP-Regulated Environment
SaaS Cloud Systems: Challenges and Best Practices
IT
KeyWordsHR Management Systems | SaaS Cloud | Learning Management System | Computerized System Validation | Vendor Management
Abstract
SaaS-GxP cloud systems have become increasingly relevant in the life science industry due to their flexibility and cost-effectiveness. However, the implementation and validation of these systems present unique challenges and risks that must be carefully managed to ensure data integrity of cloud-stored data and compliance with regulatory requirements.
For Human Resources (HR) management in particular, major risks include potential data breaches, unauthorized access to sensitive data stored in the cloud and the non-availability of the cloud-based infrastructure. These risks require robust operative measures to be implemented to ensure data privacy and integrity. Due to frequent updating and upgrading in the cloud environment, maintaining a validated state of the system inherits new challenges for companies.
In this regard, vendor management is critical to a compliant state, as the activities for staying compliant are shared between the customer and the vendor. Clear communication and agreements are necessities for a compliant system in the cloud and its operation by the cloud system provider to guarantee performance and functionality of the system.
In this study, challenges and opportunities presented by a cloud-based human capital management system widely used in the pharmaceutical industry are taken into aspect in order to achieve compliance and integrity and leverage the benefits of a cloud-based system.
 | Dr. Thomas Walter With professional consulting experience applied in numerous project activities in the pharmaceutical and medical device industries, Thomas specializes in Computerized System Validation, including HR Management Software Solutions, Data Historians, Manufacturing Execution Systems and Deviation Management Software. Coming from Life Science, he has long-standing experience in research with a PhD in Biochemistry and is TÜV-certified in Project Management, GMP Management and Quality Management. |
Abstract
SaaS-GxP cloud systems have become increasingly relevant in the life science industry due to their flexibility and
