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Validating a cloud hosted LIMS

A cloud hosted LIMS shifts some responsibility to the vendor, infrastructure, hosting, patching, but the obligation to validate the system for your specific intended use stays with your organization. The vendor's own validation of the underlying platform supports your work, it does not substitute for it.

What the vendor typically covers

A reputable cloud LIMS vendor usually validates the core platform itself, infrastructure security, uptime, and baseline functionality, and can supply documentation to support that. This is genuinely useful and saves your team from having to validate things you have no visibility into, like the underlying database engine.

What stays your responsibility

Your specific configuration, workflows, integrations with other lab systems, and the way your team actually uses the platform are not something the vendor can validate on your behalf, because the vendor does not know your intended use in that detail. This is the Category 4 configured software problem discussed elsewhere on this site, applied specifically to a cloud LIMS.

Questions worth asking a cloud LIMS vendor

Ask exactly what the vendor's own validation covers, in writing, and where their documentation stops. Ask how you will be notified of an update to the underlying platform before it reaches your production environment, since a cloud hosted system updates on the vendor's schedule, not yours.

See what a validation package looks like when it builds itself

A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.

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