Practical experience with Cloud Qualification

This video provides an in-depth exploration of practical cloud qualification within regulated GxP environments, particularly for the life sciences industry. Epista Life Science, a consultancy focused on improving regulatory compliance, presents a structured approach to address the complexities of moving IT solutions to the cloud. The discussion begins by establishing that while cloud adoption offers numerous benefits, it does not inherently eliminate compliance challenges. Instead, it shifts the nature of control and responsibility, necessitating a robust oversight strategy from the regulated company.

The presentation delves into various "as a Service" models, from colocation to Software as a Service (SaaS), highlighting how the degree of control relinquished to the cloud service provider increases with each model. A core theme is the critical importance of oversight, as regulated companies transfer procedural controls for aspects like patching, version upgrades, and underlying IT stack maintenance to the provider. The speakers emphasize that a successful cloud transition requires a comprehensive plan encompassing vendor assessment, service level agreement (SLA) negotiation, and a crucial, often overlooked, exit strategy to ensure data control and portability.

A significant portion of the webinar is dedicated to a unique "cloud compliance verification" framework. This framework utilizes a detailed spreadsheet to systematically link relevant regulatory requirements (such as EU Annex 11 and 21 CFR Part 11) to the specific responsibilities of both the cloud service provider and the regulated customer. A practical case study involving the qualification of Office 365 for GxP activities illustrates how this framework is applied, referencing Microsoft's standard SLAs and SOC 2 reports. The video concludes by introducing "Automated Boost," a tool designed to automate manual compliance tasks and periodic reviews, demonstrating its use for checking multi-factor authentication (MFA) status and monitoring Microsoft's Message Center for critical updates, thereby enabling continuous control and compliance in the cloud.

Key Takeaways:

• Cloud Adoption Shifts, Not Eliminates, Compliance Burden: Moving to cloud solutions like Office 365 or Veeva does not make GxP compliance challenges disappear; it transforms them, requiring regulated companies to maintain vigilant oversight and adapt their control strategies.
• Oversight is Paramount in Cloud Environments: When relinquishing control over underlying IT infrastructure (e.g., patching, OS maintenance, firewall configurations) to a cloud service provider, the regulated company must establish robust oversight mechanisms to ensure the provider's procedures meet compliance standards.
• Structured Cloud Qualification Process: A successful cloud transition should follow a familiar IT implementation process, including a detailed planning phase (cloud strategy, vendor assessment, SLA negotiation), an explicit exit strategy, and a tailored implementation phase.
• The Importance of an Exit Strategy: A clear exit strategy is an integral part of cloud transition planning, addressing how data will be extracted and retained in a usable format if the company decides to change providers or return to an on-premise solution, ensuring continued data control.
• "Light IQ" for Cloud Solutions: For cloud implementations, the Installation Qualification (IQ) can be a "light IQ," focusing primarily on the client-specific configuration of the cloud account, environment, users, groups, and integrations, rather than extensive testing of the underlying infrastructure managed by the provider.
• Cloud Compliance Verification Framework: A "massive spreadsheet" approach is recommended to systematically link general regulatory requirements (e.g., EU Annex 11, 21 CFR Part 11) to specific interpretations, additional client-specific requirements, and the documented procedural responsibilities of both the cloud service provider and the customer.
• Leveraging Cloud Service Provider Documentation: Regulated companies should rely on and reference documentation provided by the cloud service provider, such as standard SLAs and third-party audit reports (e.g., SOC 2 reports for Microsoft Office 365), to demonstrate the provider's adherence to controls.
• Continuous Operation and Maintenance (O&M) with a "Control Wheel": Cloud compliance requires ongoing O&M activities, which can be organized using a "control wheel" defining daily (e.g., general cloud management), monthly (e.g., account cleanup), quarterly (e.g., account access reviews), and yearly (e.g., re-verification of cloud compliance) recurring tasks.
• Automating Repetitive Compliance Tasks: Many recurring cloud O&M tasks, such as checking system health, user configurations (like MFA status), or monitoring provider updates, are manual and time-consuming. Automation tools can significantly save time and money by performing these "point-and-click" activities.
• Monitoring Provider Updates (Microsoft Message Center): For SaaS solutions like Office 365, it is critical to regularly monitor the provider's message center (e.g., Microsoft Message Center) for notifications on updates, issues, and planned changes, assessing their impact on control and compliance.
• Data Lifecycle and Cloud Retirement: Just like on-premise systems, cloud systems require consideration for data lifecycle management and system retirement, ensuring data integrity and accessibility even after a system is decommissioned or a cloud service is terminated.

Tools/Resources Mentioned:

• Automated Boost: A record and replay test automation tool demonstrated for monitoring and automating compliance tasks in cloud environments.
• Microsoft Office 365: Used as a practical case study for cloud qualification and automation.
• Microsoft Azure: Mentioned in the context of Microsoft's cloud infrastructure responsibilities.
• Microsoft Message Center: A platform for Microsoft to communicate updates, issues, and planned changes to its services.

Key Concepts:

• XaaS (Everything as a Service): A broad category of cloud computing services, encompassing Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS), each with varying levels of control shared between provider and customer.
• Cloud Qualification: The process of formally documenting that a cloud-based system or service meets predefined regulatory requirements and is fit for its intended GxP-regulated purpose.
• Cloud Compliance Verification: A methodology, exemplified by a detailed spreadsheet, for systematically mapping regulatory requirements (e.g., GxP, 21 CFR Part 11, EU Annex 11) to the controls and responsibilities of both the cloud service provider and the regulated customer.
• Light IQ (Installation Qualification): A streamlined approach to IQ for cloud solutions, focusing on the configuration and integration aspects managed by the customer, rather than extensive testing of the underlying infrastructure which is the provider's responsibility.
• Control Wheel: A visual framework used to define and schedule recurring operational and maintenance activities necessary to maintain continuous compliance and control over cloud solutions, categorizing tasks by frequency (daily, monthly, quarterly, yearly).
• GxP (Good x Practice): A collection of quality guidelines and regulations for various aspects of regulated industries, particularly life sciences, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
• 21 CFR Part 11: Regulations from the U.S. Food and Drug Administration (FDA) that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• EU Annex 11: An annex to the European Union's Good Manufacturing Practice (GMP) guidelines, providing specific requirements for computerized systems used in pharmaceutical manufacturing.
• MFA (Multi-Factor Authentication): A security system that requires more than one method of authentication from independent categories of credentials to verify the user's identity for a login or other transaction.