SaaS & Cloud Validation in a GxP Environment: a Complete Roadmap for QA, IT and Validation

In recent years, many Life Science companies have increasingly adopted cloud solutions (SaaS, PaaS, IaaS) to improve flexibility and speed. However, this also introduces new GxP compliance challenges: data integrity, system availability, change management, and shared responsibility with the provider.

The golden rule, however, has not changed:
If a system impacts GxP data or processes, it must be controlled and validated.
And even when the system is “owned by the vendor”, final responsibility for compliance is not delegable: the regulated company must govern the provider through contracts, audits, and robust internal processes.

This page is a complete, audit-ready roadmap to:

• decide what to validate and to what extent (risk-based),
• define roles and responsibilities (shared responsibility),
• qualify vendors and manage evidence,
• build Data Integrity controls in line with ALCOA+,
• maintain the validated state through change control and continuous compliance.

What does it mean to “validate” a SaaS/Cloud system in GxP (in one sentence)

Validating a GxP cloud system means demonstrating, with documented evidence, that:

• the system is fit for intended use,
• risks to patients, products, and data are identified and mitigated,
• the system remains in a controlled state after go-live
  (because in the cloud “something is always changing”).

CSV vs CSA: what really changes in the cloud

Traditional CSV (GAMP 5, Part 11, Annex 11) remains the reference for “what” (requirements and expectations).
The more modern CSA (Computer Software Assurance) approach focuses instead on “how”: less bureaucracy, more focus on critical functions and risk.

In practice, this means:

• not “less control”,
• but better, proportionate, and sustainable controls over time.

The regulatory framework you should keep “at hand”

For a GxP SaaS/Cloud system, the minimum expected framework typically includes:

• FDA 21 CFR Part 11 (electronic records and signatures)
• EU GMP Annex 11 (computerised systems, 17 clauses across the lifecycle)
• Data Integrity / ALCOA+ (principles plus technical and procedural controls)

Practical note:
Part 11 is highly technical and focused on records/signatures; Annex 11 is strongly lifecycle-oriented (risk management, suppliers, configuration management, security, backup). In global projects, both perspectives must be covered.

Why the cloud “complicates” — and at the same time simplifies — validation

The cloud introduces elements that change the rules:

• Shared Responsibility: Some controls are performed by the vendor, but you must demonstrate governance (contracts, audits, oversight).
• Frequent updates: Especially in SaaS, upgrades and patches are frequent → operational and continuous change control is essential.
• Multi-tenancy (often): You must understand how data are segregated between customers.
• Remote access: Great for operations, but requires discipline on access control, roles, and audit trail review.
• Vendor dependency: Incidents, downtime, RCA, backup/restore become partly vendor-dependent.

10-Step Roadmap to Validate (and Maintain) a GxP SaaS/Cloud System

1) Determine GxP impact and intended use

Before talking about testing:

• Which processes does the system support? (GMP, GCP, GLP…)
• What type of data does it manage? (quality data, batch records, training, deviations, etc.)
• Direct or indirect impact on quality and patient safety?

Typical outputs:

• GxP impact classification
• Scope definition (in scope / out of scope)

2) Define governance and roles (before validation documents)

In the cloud, governance is half of compliance.

Minimum roles:

• System Owner (business)
• IT Owner / Administrator (technical)
• QA / CSV / Validation (compliance governance)
• Vendor Owner (supplier and contract management)

Audit-ready tip:
Formalise a RACI matrix already in the Validation Plan (who authors/approves URS, executes tests, approves release).

3) Qualify the vendor (before trusting their evidence)

The SaaS/Cloud provider becomes an extension of your process and must be verified, audited, governed, and monitored.

Typical deliverables:

• Vendor assessment / audit report
• Quality Agreement / SLA / security appendices
• Monitoring plan (SLA review, certifications, periodic assessments)

4) Perform Risk Assessment (ICH Q9) and define the validation effort

This is where you decide how much to test and how much to document.

Typical cloud risks:

• Connectivity / availability
• Frequent changes
• Data residency
• Vendor lock-in
• Incidents and reliance on vendor RCA

Outputs:

• Risk assessment with mitigations linked to tests
• Decision on what to test internally vs what to accept from the vendor (with rationale)

5) Write a cloud-aware Validation Plan

A clear plan avoids misunderstandings and reduces timelines.

Key elements (often requested in audits):

• System description and impact
• Roles and responsibilities
• Expected deliverables (URS, RA, IQ/OQ/PQ, RTM, VSR, SOPs)
• Strategy for reuse of vendor evidence (e.g. vendor testing/FAT) and what you will supplement

6) Define requirements: URS + configuration specifications (FS/CS)

The URS is your contractual baseline and the basis for testing: every requirement must be verifiable.

Commonly critical SaaS requirements:

• Planned and communicated updates
• Availability of test/sandbox environments
• Support and assistance requirements (SLA)
• Compliance controls (audit trail, electronic signatures, access control)

7) Plan IQ/OQ/PQ realistically for the cloud

In SaaS, IQ is not “installing a server”, but rather verification of:

• Correct instance/tenant
• Base configurations
• Prerequisites (browsers, access, integrations)
• Vendor-provided infrastructure evidence (where applicable)

The lifecycle remains “classic” (definition → testing → release), but adapted:
IQ focuses on instance/infrastructure; OQ/PQ may require vendor involvement and dedicated environments.

8) Build traceability that auditors appreciate

The RTM (Requirements Traceability Matrix) must demonstrate full coverage, especially for critical and compliance requirements.

Useful fields: Requirement ID, category, IQ/OQ/PQ test case, pass/fail status, notes, deviations.

9) Controlled release: training, SOPs, support

Before go-live, audit-ready means having:

• SOPs for use, account management, audit trail review, backup (if applicable)
• Completed training with evidence
• Defined support/service desk
• Verified data migration (if applicable)

10) Post go-live: change control and continuous compliance

(the part that makes or breaks an audit)

In the cloud, the validated state must be actively maintained:

• Change control for vendor releases, configuration changes, patches
• Incident management, RCA, CAPA
• Periodic review (“system health check”)
• Continuous audit readiness
• Decommissioning / exit strategy

Your minimum “Audit Pack” for a GxP SaaS/Cloud system

If an auditor arrived tomorrow, what should you show without panic?

Typical package:

• Validation Plan
• URS + configuration (FS/CS)
• Risk Assessment
• IQ/OQ/PQ (protocols + evidence)
• RTM
• Validation Summary Report
• Operational SOPs + training records
• Vendor qualification + Quality Agreement
• Change control log + periodic review report

This approach is consistent with the audit-ready, operational mindset described in the guide (with checklists and templates).

Common mistakes I see most often (and auditors notice immediately)

• “It’s SaaS, so validation is not required” → false and dangerous.
• Delegating everything to the vendor without audits and a Quality Agreement.
• Tick-the-box documentation while ignoring real risks (CSA goes in the opposite direction).
• Ignoring SaaS updates (the real long-term compliance killer).

FAQ (Featured Snippet / People Also Ask)

Does a SaaS used in GMP need to be validated?
Yes, if it impacts GxP data or processes. “Cloud” is not an excuse: the strategy changes, not the obligation.

Who is responsible for compliance if the system belongs to the vendor?
Final responsibility remains with the regulated company, which must govern the provider through contracts, audits, and processes.

Can vendor testing be reused?
Yes, but adequacy must be assessed and gaps integrated where needed (risk-based). Reuse must be defined and justified in the Validation Plan.

What do FDA/EMA focus on for cloud systems?
Governance, data integrity, access control, audit trails, change control, testing evidence, and vendor qualification.

If you want to turn this roadmap into an audit-ready implementation with checklists and operational templates (Validation Plan, URS, RTM, IQ/OQ/PQ, Change Log, etc.), you can find the complete guide “SaaS & Cloud Validation: Guide to GxP Implementation” for sale on guidegxp.com.