Quality Agreements with Cloud Providers

Having a quality agreement with a cloud provider is crucial for several reasons:

Ensure Regulatory Compliance

A quality agreement helps ensure the cloud provider’s services and processes comply with relevant regulations and guidelines, such as GxP (Good Practice) requirements from agencies like the FDA, EMA, and MHRA. It defines the roles, responsibilities, and expectations for maintaining data integrity, security, and quality standards throughout the product lifecycle.

Delineate Responsibilities

Cloud services often involve complex technology stacks and multiple subservice providers. A quality agreement clearly delineates the responsibilities of the regulated company and the cloud provider, ensuring that critical activities like change control, incident management, data governance, and security controls are properly addressed and assigned.

Establish Service Levels

The quality agreement specifies the agreed service levels, performance metrics, and key performance indicators (KPIs) that the cloud provider must meet, such as application availability, support response times, data security breach notification timelines, and system performance. This helps maintain the required quality of service.

Enable Oversight and Audits

The agreement outlines provisions for initial qualification audits, periodic audits, and inspections by the regulated company to assess the cloud provider’s compliance with the agreed terms. It also defines processes for managing audit findings and corrective actions.

Ensure Data Integrity and Security

Addressing data-related requirements, such as data ownership, privacy, protection controls, retention, archiving, and disposal processes, is critical to ensuring data integrity and security throughout the data lifecycle.

Manage Third-Party Risks

The agreement establishes guidelines for the approval process and compliance requirements when the cloud provider uses subcontractors or third-party services, mitigating associated risks.

Contents

A quality agreement between a regulated company (customer) and a Cloud (SaaS, PaaS, IaaS) provider should cover the following key elements:

Roles and Responsibilities

Clearly define the roles, responsibilities, and obligations of both parties regarding:

• Regulatory compliance (GxP, data privacy, security, etc.)
• Quality management system and processes
• Change control and release management
• Incident and deviation management
• Data integrity, backup, and recovery
• Performance monitoring and reporting

Service Levels and Performance Metrics

Specify the agreed service levels and key performance indicators (KPIs) for:

• Application availability and uptime
• Support response and resolution times
• Data security and breach notification timelines
• System performance and capacity

Audits and Assessments

Outline the provisions for:

• Initial qualification audits of the SaaS provider
• Periodic audits and inspections by the regulated company
• Processes for managing audit findings and corrective actions

Data Management

Address data-related aspects such as:

• Data ownership and usage rights
• Data privacy and protection controls (as per applicable regulations)
• Data retention, archiving, and disposal processes

Subcontracting and Third Parties

Establish guidelines for:

• Approval process for use of subcontractors/third parties
• Ensuring subcontractors comply with the quality agreement
• Communication of changes impacting the regulated company

Term, Termination, and Offboarding

Specify conditions for:

• Initial term and renewal of the quality agreement
• Termination rights (e.g., for non-compliance, data breaches)
• Responsibilities during offboarding and data transition

The quality agreement should be a comprehensive yet pragmatic document that ensures the cloud solution meets the regulated company’s quality and compliance requirements throughout the engagement.