Validation
eQMS validation that starts from a validated core platform
Our core platform is validated. Your system is validated by you.
eQMS validation moves faster when your supplier's evidence is real and the boundary is written down. QMSdesk™'s core platform is validated under a QA-approved Validation Summary Report. Every engagement includes a written validation scope, so you know what's done and what remains yours.
What changes for your eQMS validation team
01
You start from evidence
Our core platform comes with a QA-approved Validation Summary Report. We'll walk you through it under a mutual NDA, and you can cite it in your supplier assessment.
02
You know exactly what's yours
A written validation scope sets out what our record covers, what you validate for your intended use, and who carries out each part.
03
Your effort follows the risk
A risk-based approach puts your testing where your intended use carries risk, and lets you draw on supplier evidence elsewhere.
Our validated core platform
QMSdesk's core platform is validated under a QA-approved Validation Summary Report. We'll walk you through the full record under a mutual NDA.
The vendor validation package, and your validation
Our record is supplier evidence. Use it in your supplier assessment, and use it to decide how much of your own testing each function needs. It doesn't replace your validation. Your intended-use decisions, procedures, data, roles, approvals and site-specific validation stay with you, in your environment.
QMSdesk gives you the tools to do that work inside the system:
The Configuration Runway
Set up and test in your real tenant in Implementation Mode. Implementation records stay out of your live metrics, and the test evidence is kept.
A signed go-live gate
Go-live takes two separately signed attestations, one for technical readiness and one for quality readiness.
A validated state that holds
After go-live, a setting that affects your validated state changes only through approved change control.
Your validation boundary, in writing
Generate a signed System Boundary Statement at any time. It shows which modules are in scope, and any module you run elsewhere reads "managed outside QMSdesk".
01
A written validation scope, every time
Every engagement includes a written validation scope. It names what our validation covers, what you'll validate for your intended use, and who carries out each part, so the boundary is agreed before the work starts.
Implementation, migration and validation support are each scoped separately, in writing. You choose how much of your share to carry yourself.
02
Risk-based validation, aligned with CSA
FDA's guidance Computer Software Assurance for Production and Quality Management System Software was finalized on September 24, 2025, and the current version was issued on February 3, 2026. It asks for assurance in proportion to risk.
Akatalyst's practitioners bring that risk-based approach to your share of the work.
Akatalyst validation services
QMSdesk™ is an Akatalyst platform. Akatalyst's Comprehensive Validation Services are built to reduce over-validation and increase defensibility with risk-based execution:
- computerized system validation (CSV) and Computer Software Assurance (CSA);
- SaMD and medical-device validation;
- cloud and infrastructure qualification;
- process and equipment lifecycle qualification;
- the Validation Acceleration Program: CSA and CSV execution with reusable evidence patterns.
Akatalyst's advisory practice is led by a founder with 25 years in regulated life-sciences quality.
CSA360™ is Akatalyst's risk-based Computer Software Assurance decision engine. It helps regulated organizations right-size validation and record the rationale behind each decision.
Questions buyers ask
Can we reuse your validation evidence?
You can use it as supplier evidence: in your supplier assessment, and to decide how much of your own testing each function needs. It doesn't replace your validation. Your intended use, configuration and procedures are validated by you, and your written validation scope sets out what that involves.
Can we see the full validation record?
Yes. We'll walk you through the full record, including the Validation Summary Report, under a mutual NDA.
Who carries out our validation?
You do, with Akatalyst's validation practitioners alongside you if you choose. Validation support is scoped separately, in writing, before the work starts.
How does CSA change our validation effort?
FDA's final CSA guidance asks for assurance in proportion to risk. You can focus scripted testing on the functions that matter most to your intended use, and draw on supplier evidence for the rest.
See the record, and the system behind it
Bring one workflow, and ask us anything about how it's validated. We'll show you QMSdesk running it. Early-stage and growth teams can also join the 2026 Early Adopter Program.