Compliance Roadmap
LIMS BOX is workflow infrastructure that supports your compliance journey — not a certification.
← Back to lims.botWhat LIMS BOX Does
LIMS BOX is designed to support regulated lab workflows. It provides the tooling labs need to build consistent, auditable processes — but does not replace the validation work your lab must perform and document itself.
Audit Trails
Every sample event, user action, and result change is logged with a timestamp and user record — ready for your review.
Access Control
Role-based access so the right staff see and act on the right data. Reviewers, analysts, and administrators each have appropriate permissions.
Workflow Documentation
SOPs, method templates, and step-by-step workflows are configurable per deployment to match your lab's documented procedures.
Local / Offline Operation
Full functionality without an internet connection. Deployment-specific hardware means no cloud dependency and complete data sovereignty.
Human Approval Steps
Results, chain of custody, and QC decisions require human review and sign-off before records are finalized — by design.
Validation Support Services
We provide deployment support, configuration review, and documentation to help your team execute your own validation process.
What LIMS BOX Does NOT Do
- ✗LIMS BOX does not certify a lab. Accreditation requires an independent, accredited reviewer — not a software vendor.
- ✗LIMS BOX does not replace customer validation. Each customer validates its own workflows, SOPs, users, instruments, and reporting process. LIMS BOX supports that work — it does not substitute for it.
- ✗LIMS BOX does not substitute for a qualified reviewer. Human oversight by qualified personnel remains required for all compliance-sensitive decisions.
- ✗LIMS BOX does not make compliance claims on your behalf. Any compliance claim your lab makes is yours — based on your validation, your SOPs, and your documented process.
How We Support CLIA-Aware Workflows
LIMS BOX is designed with CLIA laboratory requirements in mind. The platform includes workflow controls for test ordering, result entry, QC review, and chain of custody — all with documented audit trails and human approval steps. Customers using LIMS BOX in a CLIA-applicable setting validate these workflows themselves as part of their own compliance process.
“CLIA-aware workflows” means the tooling is designed to support these requirements — not that LIMS BOX is a product that fulfills CLIA requirements on its own.
How We Support ISO 17025-Aligned Workflows
ISO 17025-aligned means LIMS BOX includes tooling relevant to ISO 17025 laboratory requirements — document control, equipment records, method tracking, proficiency testing records, and audit trail support. These are workflow supports designed to facilitate a lab's own ISO 17025 compliance work, not a product certification.
How We Support Part 11-Compatible Workflows
21 CFR Part 11 governs electronic records and electronic signatures in regulated industries. LIMS BOX includes controls for electronic signatures, audit trails, access management, and record retention that are designed to support Part 11-compatible processes. Customers in regulated industries validate these controls as part of their own compliance work.
“Part 11-compatible support” means the feature set is designed to be compatible with Part 11 requirements — not that LIMS BOX has been submitted to or reviewed by any regulatory body.
Deployment and Validation Support Services
Every LIMS BOX deployment includes hands-on configuration support, workflow documentation, and a validation support package. Our team works with your lab to configure workflows that match your SOPs, document the deployment, and prepare the materials your team needs to execute your own validation process.
Deployment Services
On-site or remote setup, hardware configuration, and workflow configuration to match your lab.
Validation Support
Documentation, configuration records, and workflow specification to support your IQ/OQ/PQ process.
Ongoing Support
Continuous updates, monitoring, and access to our team as your lab's needs evolve.
Questions? info@lims.bot