Vendor Qualification for SaaS/Cloud GxP: How to audit, qualify and govern vendors

In the cloud, the provider is not “just an IT vendor”: it is part of your Quality System.

For this reason:

• vendor qualification is not only a best practice, but a regulatory and operational requirement,
• and it must be maintained over time: a vendor qualified today can become a risk tomorrow if the platform, release process or security management changes.

The guidance summarizes it clearly: qualification of cloud/SaaS vendors is essential; vendor management includes initial assessment, qualification audit, Quality Agreement and continuous monitoring (SLAs, certifications, periodic audits).

Step by step: a Vendor Qualification process that stands up to inspection

Step 1 — Initial assessment (vendor assessment)

Objective: determine whether it makes sense to invest time (and money) in qualification.

What to collect:

• service overview (SaaS? multi-tenant? data residency?)
• GxP impact and process criticality
• available evidence (certifications, SOC reports, security policies, SDLC)

Output:

• vendor risk rating / criticality
• decision “audit yes/no” and audit depth

Step 2 — Qualification audit (on-site or remote)

An effective audit is not an IT questionnaire.

A cloud/SaaS audit in a GxP context should at least cover:

• vendor QMS
• software development / SDLC
• infrastructure management
• information security
• backup / disaster recovery
• Part 11 / Data Integrity compliance
• vendor regulatory competence

Audit-room tip: always ask for concrete examples (“show us how you manage X”) and request evidence, not just statements.

Step 3 — Quality Agreement (QA) + SLA + annexes

The Quality Agreement is the contractual translation of compliance.

Key clauses that must be included:

• roles and responsibilities (linked to the Shared Responsibility Model)
• change management (notifications, approvals, minimum information)
• data management (ownership, protection, return, export)
• right to audit
• non-conformance management: notification of significant deviations

Step 4 — Controlled go-live (vendor as a validation stakeholder)

Here you must avoid a common mistake: validating against the vendor instead of with the vendor.

Best practices:

• define in the Validation Plan how vendor evidence will be used
• establish escalation channels (incident, change, RCA)
• clarify management of sandbox / test environments

Step 5 — Continuous monitoring (the piece that is almost always missing)

In the cloud, qualification is not an event: it is a process.

What to monitor:

• SLA and performance trends
• change notifications and quality of release notes
• incidents, RCA and response times
• up-to-date certifications / SOC reports
• periodic audits / vendor review meetings

The guidance recommends integrating the vendor into change and incident processes: every communicated change must enter internal change control; every significant incident must be handled as a deviation/CAPA, often supported by a vendor RCA that is assessed and retained as evidence.

Special case: qualifying hyperscaler IaaS providers without direct audits

In practice, many companies do not directly audit hyperscalers, but rely on:

• third-party reports (SOC)
• certifications (ISO, etc.)
• compliance documentation and standard controls

The key is to make this approach risk-based and documented:
“Why is this sufficient in our context?”

Red flags (if you see them, stop or apply strong mitigations)

• inability to clearly explain SDLC, change and release management
• lack of a robust incident/RCA process
• no verifiable evidence (only “trust me”)
• refusal to accept minimum clauses (audit right, change notification, data export)

For operational checklists (vendor assessment, audit focus, QA clauses) and a complete approach to cloud/SaaS vendor qualification in a GxP context, see the guide “SaaS & Cloud Validation: Implementation Guide for GxP” on guidegxp.com.