Validation of SaaS Cloud Platforms for Pharma Industry: Balancing Innovation with Data Integrity in a GxP and non-GxP landscape

Pharmaceutical industries are rapidly adopting Cloud Software-as-a-Service (SaaS) platforms to streamline process, enhance collaboration and empower clinical trials. This presents both opportunities and challenges. While SaaS offers scalability, cost-effectiveness, improved collaboration (allowing remote work), ensuring data integrity is paramount. This workshop will explore the latest trends in SaaS validation for GxP (GMP, GLP, GCP) and non-GxP applications, highlighting key data integrity challenges. We will discuss evolving regulatory landscape, emphasizing the importance of adhering to regulations like 21CFR Part 11 and EU Annex 11 for electronic records and signatures and guidelines such as GAMP5 2nd edition. The workshop concludes by presenting key challenges when validating a Cloud Saas platform which will be discussed in a roundtable format in groups, boiling down towards a roadmap to best navigate these challenges and achieving a successful validation in this dynamic field.

Key challenges:
1. Shared Responsibility Model: Balancing the responsibilities of data security and integrity between pharmaceutical companies and cloud SaaS providers
2. Vendor Lock-In: Mitigating the risk of being locked to a single SaaS provider, potentially hindering future data transferability.
3. Data Residency and Control: Ensuring compliance with regional and global data privacy regulations, such as GDPR, and maintaining control over where sensitive clinical trial data is stored.
4. Audit Trail Comprehensiveness: Guaranteeing a comprehensive and auditable record of all data activity within the SaaS platform, including user actions and system changes.
5. Integration with existing systems and scalability for emerging technologies: Assessment of integration with current technologies and emerging technologies (for enhanced data security and traceability), while validation procedures remain robust.

Shikha Raikundalia

Hovione

Appearances