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Cloud solutions for GxP laboratories: considerations for data storage
Scott Davis1, Joel Usansky2, Shibani Mitra-Kaushik3
1Information Technology, PPD, 2240 Dabney Road, Richmond, VA 23230, USA.
Bioanalysis
|September 13, 2021
Summary
Cloud storage offers efficient, cost-effective solutions for pharmaceutical drug development data. This review defines best practices for laboratory data integrity, security, and access control in GxP cloud environments.
Area of Science:
- Pharmaceutical industry
- Drug development
- Laboratory data management
Background:
- Increasing complexity of data storage needs in global drug development.
- Growing adoption of cloud services due to efficiency and cost-effectiveness.
- Addressing user hesitancy towards cloud implementation in regulated environments.
Purpose of the Study:
- To discuss challenges and considerations for cloud storage of laboratory GxP data.
- To define best practices for implementing cloud storage in GxP laboratories.
- To ensure data integrity, security, and global accessibility.
Main Methods:
- Review of current challenges in pharmaceutical data storage.
- Analysis of GxP compliance requirements for cloud environments.
- Identification of best practices for cloud data management.
Main Results:
- Cloud services present attractive solutions for pharmaceutical data storage.
- Key considerations include data integrity, security, and access control.
- Best practices are essential for successful GxP cloud implementation.
Conclusions:
- Cloud storage is a viable and increasingly adopted solution for drug development data.
- Careful planning and adherence to best practices are crucial for GxP compliance.
- Effective cloud strategies enhance global data accessibility and resource management.
