Cloud, SaaS and vendor qualification
Relying on a SaaS vendor or cloud platform for GxP work? Qualify the vendors and cloud platforms your validation depends on. Then keep cloud systems in a validated state as they change.
The challenges this solves
We cannot tell what vendor evidence we can rely on
Without a clear audit, we re-test what the vendor already proved.
SaaS releases keep coming
Every update risks our validated state, and manual re-validation cannot keep up.
Supplier oversight is inconsistent
Vendors are qualified once and rarely looked at again.
What we deliver
- On-site or remote supplier audits of software vendors against your GxP requirements
- IaaS, PaaS and SaaS providers assessed for GxP suitability
- Review of vendor SDLC, testing and release controls
- Security and data controls: access, data segregation, backup and continuity
- Evidence-leverage map: what you can rely on versus what you must test
- Continuous validation of cloud changes with regression suites and automated compliance scans
- Policy-as-code monitoring of security policies and controls on AWS, Azure and GCP
- Periodic re-qualification and supplier monitoring
Systems and tools
- AWS
- Microsoft Azure
- Google Cloud (GCP)
- Veeva
4 steps, clear deliverables
- 01
Scope
Identify vendors and the risk they pose to your GxP use.
You receive: Vendor and cloud audit plan and checklist
- 02
Audit
Assess the vendor's quality system and controls.
You receive: Audit report with risk-rated findings
- 03
Determine
Map which evidence you can leverage and which gaps need your own controls.
You receive: Evidence-leverage determination aligned to CSA
- 04
Monitor
Follow up on corrective actions and re-qualify on a risk-based schedule.
You receive: Re-qualification schedule
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- CROs & clinical
Related services
Questions we hear most
Why does vendor qualification matter under CSA?
CSA lets you leverage qualified vendor evidence. An audit shows what you can rely on, so you only test what you must.
Which compliance frameworks are in scope?
21 CFR Part 11, EU Annex 11 and GxP (GLP, GCP, GMP). Assessments can also cover HIPAA, HITRUST, SOC 2, ISO 27001 and GDPR.
What service models do you offer?
A managed service subscription, or a co-managed approach where you keep oversight. Packages range from small biotech to multi-cloud enterprise needs.
How is a qualification audit priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Qualify the vendors your validation depends on
Get a scoped, fixed-fee quote for vendor and cloud qualification.