Audit-ready lab operations, without the audit fire drill
Audit-ready lab operations continuously capture source data, sample lineage, QC checks, e-signatures, and approvals as work happens.
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Trusted by 200+ life science labs
How this fits your team's daily routine
Morning: Analyst
The right method and controls are confirmed before work starts
The active SOP version, required fields, analyst role, sample context, instrument status, and approval path are connected to the record before execution begins.
Midday: QC reviewer
Gaps surface while they can still be fixed
Missing context, failed checks, incomplete calculations, deviations, unsigned steps, and overdue reviews are flagged and routed before the record reaches final approval.
End of day: Quality lead
The evidence is already assembled
Source files, audit history, method version, sample lineage, exception resolution, electronic signatures, and approvals remain connected to the underlying work.
Everything included, built around how regulated lab teams work
Keep the ELN, LIMS, QMS, instrument systems, or document tools that still work. Scispot connects them into one controlled workflow or provides native applications where gaps remain.
Controlled Method Execution
Define the intended workflow, required records, user roles, current SOP or method, signature steps, review sequence, and approval criteria.
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Quality Checks Before Final Review
Apply customer-approved rules for required fields, calculations, sample state, instrument status, analyst qualification, method selection, and record completeness.
Scispot's default posture is to flag, block, route, and document. Your Quality team retains judgment and regulated sign-off.
Living Evidence in Trust Vault
Keep audit trails, approvals, signatures, validation records, test evidence, exception history, controlled reports, and recurring compliance artifacts together.
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Ask what is missing before
the record reaches Quality.
It does not replace Quality judgment, validation approval, or regulated sign-off.
Why regulated labs choose
Scispot for audit-ready operations
Evidence is created during the work
The audit trail remains connected to the sample, method, instrument, result, exception, and approval it supports.
Quality remains in control
Automated rules identify issues and route work. People retain control over review, judgment, validation, and sign-off.
Your current systems can remain
Scispot can work across existing ELN, LIMS, QMS, SDMS, document, instrument, and data systems.
Validation support is part of the engagement
The Scispot team helps define intended use, controls, test evidence, traceability, and change impact.
Specialists configure the complete workflow
You work with scientists, engineers, lab software activation experts, and compliance specialists—not only a software support queue.
01
Controlled method execution
Method setup → Analyst execution → QC checks → E-signature → Review → Approval → Audit trail
Keep the right method, analyst, instrument, sample, calculation, and approval path connected throughout execution.
02
Review by exception
Automatically surface failed checks, missing context, calculation issues, unsigned records, overdue approvals, and unresolved deviations.
Your reviewers focus on the records that require judgment rather than manually checking every field.
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03
Inspection evidence retrieval
Search by sample, run, batch, analyst, instrument, method, exception, or approval. Retrieve the supporting evidence without searching across folders and systems.
Frequently asked questions
Does Scispot make my lab compliant?
No software alone makes a lab compliant. Scispot supports controlled workflows and evidence. It supports ALCOA+ data-integrity principles and can be configured for 21 CFR Part 11-controlled workflows. Your organization remains responsible for intended use, procedures, validation decisions, training, operation, and regulated approvals.
What compliance evidence can Scispot capture?
Scispot can connect user identity, roles, timestamps, source files, sample lineage, instrument and method context, SOP versions, QC checks, calculation history, change reasons, exception resolution, electronic signatures, review, approval, and validation evidence.
The exact evidence depends on your intended use and connected systems.
Can Scispot work with our existing ELN, LIMS, QMS, or document system?
Yes. Scispot can operate across native and third-party systems. You can keep the applications that work and use Scispot to connect data, controls, approvals, reports, and evidence across them.
What validation support does Scispot provide?
Depending on scope, Scispot can support intended-use definition, risk assessment, system and configuration documentation, IQ/OQ materials, test scripts, traceability, acceptance testing, validation summaries, and change-impact evidence. Your Quality organization retains validation ownership and approval.
Can AI make or approve regulated Quality decisions?
Human approval remains the default at regulated decision points. Scispot’s agents can identify gaps, summarize context, flag issues, route work, and document actions. They do not silently alter regulated data or replace Quality sign-off.
What labs say
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Let's map your audit-ready workflow
FAIR data • pipelines • automation
Instruments • ELN/LIMS/SDMS • 200+ connectors
FAIR data • pipelines • automation
Instruments • ELN/LIMS/SDMS • 200+ connectors