Scispot Trust Vault

Compliance Evidence, Created As Work Happens.

Map requirements to controls. Connect controls to evidence. Keep the proof close to the work, ready for Quality, sponsors, and auditors.

Book a Demo
Ask about Validation Care
Scispot Lab Operating System diagram: AI Agents, Jupyter Hub and third-party instruments connected through the Digital Brain to ELN, LIMS, SDMS, QMS, app integrations, Smart Actions and Trust Vault

Trusted by 200+ life science labs

The Evidence Gap

The evidence exists.
‍Quality still has to reconstruct it.

Scattered records

Source files, signatures, and validation artifacts sit across systems.

Missing context

The record exists. Its connection to the control is unclear.

Repeated testing

Vendor evidence and customer validation responsibilities overlap.

Late surprises

Missing proof surfaces when the inspection is already approaching.

Protocols, samples, training, instrument files, and approvals live in different places. When someone asks “Prove what happened,” Quality has to rebuild the story.

Built for quality-critical laboratory operations

Diagnostics
Biotech R&D
Pharma QC
CROs & service labs
From Requirement to Proof

A Folder Stores Documents. Trust Vault connects controls to Evidence.

Beyond IQ / OQ / PQ

One Evidence Layer.
Across Your Regulated Obligations.

CAP / CLIA

Sample traceability, QC, equipment records, procedures, and result review.
CLINICAL LAB OPERATIONS

GLP / GxP

Controlled execution, source data, review, approval, and change history.
REGULATED SCIENTIFIC WORK

21 CFR Part 11

Electronic records, signatures, access controls, and audit-trail evidence.
ELECTRONIC RECORD CONTROLS

ALCOA+

Identity, timestamps, source lineage, record integrity, and evidence availability.
DATA-INTEGRITY PRINCIPLES

Validation

Intended use, requirements, risk, IQ/OQ/PQ, traceability, and summaries.
VALIDATION LIFECYCLE

Quality requirements

Sponsor obligations, internal controls, and site-specific evidence needs.
CUSTOMER-DEFINED SCOPE
A Clear Validation Boundary

Reuse Relevant Evidence.
‍Validate Your Intended Use.

Review Scispot platform evidence alongside your configuration, procedures, and PQ/UAT. Quality sets the validation strategy and approves regulated use.

SCISPOT
Platform evidence
Installation and standard functionality
Technical controls
Available IQ / OQ evidence
Release and change documentation
CUSTOMER QUALITY
Intended-use evidence
User requirements and configuration
Procedures and training
PQ / UAT and customer-specific risks
Final approval for regulated use
Trust Vault
A shared home for the evidence boundary.
Validation boundary
Trust Vault
A shared home for the evidence boundary.
Validation boundary
Under the Hood

Keep The Evidence Current. Keep The Quality In Control.

01

Review Evidence Gaps

Bring missing records, unresolved exceptions, and pending approvals into Quality’s review process.

Instrument data from a Thermo Fisher Orbitrap streaming at 1.2 GB per run

02

Assess Change Impact

Review releases, workflow updates, and configuration changes against the evidence that supports validated use.

Evidence and reports: audit trail report, validation summary and CAP-CLIA execution report, always ready

03

Evidence on Demand

Organize execution reports, audit histories, and validation packages for the request in scope.

Staging lakehouse transformation running with units, IDs and metadata mapped and every version kept

04

Control evidence access

Keep sensitive artifacts within a defined access scope. Review how evidence is shared with external reviewers.

Control the workflow: role-based permission, schema locked and inline editing restricted
Outcomes

Make evidence part of the workflow.

Less Reconstruction

Keep supporting records close to the work they explain.

Clear Validation Scope

Separate reusable platform evidence from intended-use testing.

Easier Evidence Retrieval

Organize the proof behind a result, change, or validation decision.

Repeatable Quality

Reuse evidence patterns as workflows, teams, and sites grow.

Trust Vault makes audit readiness part of lab execution.

Connect Quality to Execution

Keep Your QMS.
‍Strengthen The Evidence Behind It.

Use native Scispot apps, connect supported existing systems, or combine both. Start with one workflow where Quality needs better visibility.

YOUR QUALITY SYSTEM
Manage the quality process.

Your QMS can remain the home for controlled documents, training, CAPA, deviations, and change control.

Documents
Training
CAPA
Change control
SCISPOT TRUST VAULT
Connect the operational proof.

Organize the samples, runs, methods, source data, approvals, signatures, and validation evidence behind the work.

Lab records
Source lineage
Approvals
Validation

Start with one evidence request. Map the records, systems, controls, and output in scope.

Expert Support When Needed

Trust Vault Is The Product. Validation Care Is The Service.

Add specialist support around intended use, risk, qualification, and validation documentation. Scope the work to your laboratory and quality system.

Explore Validation Care
Scispot supports the process. Quality retains final approval.
Intended use
Clarify scope and regulated use.
Risk assessment
Focus testing where it matters.
Protocols
Support IQ/OQ/PQ documentation.
Execution support
Testing, deviations, and evidence.
Traceability
Link requirements to test evidence.
Change review
Assess additional validation work.

Without Trust Vault

Static Validation Documents
Manual Audit Reconstruction
Equipment Logs In Spreadsheets
Unclear Revalidation Triggers
Last-Minute Inspection Prep

Scispot Trust Vault

Structured IQ/OQ/PQ System
Immediate Audit Trail Visibility
Validated Digital Logbooks
Documented Lifecycle Controls
Continuous Compliance Readiness

If an agent acts,
define the evidence it must leave.

Include automated actions in your evidence strategy. Define the context, rules, permissions, human approvals, and outcomes required for review.
Meet Scibot
Scibot, the Scispot AI coworker
Flag Tomy’s QC deviations
Approved workflow + source records
Prepare result for review
Configured rules + permissions
Quality review before release
Accepted, rejected, or corrected
Flag Tomy’s QC deviations
Count Cynthia’s CD8 antibody lots
Find patient-042’s sample location
Flag out-of-spec results
Compare assay run results
Summarize Jeremy’s sequencing run
Built for Labs
Trained on lab data and workflows.
Secure & Compliant
Protect lab data with traceable workflows.
Always Learning
Improves with your data and feedback.

Resources

View all Resources
Software platforms manage tools. We manage outcomes.

Show Us Your Audit Question That Takes Too Long To Answer.

Bring one recurring request. We’ll map the requirement, control, evidence, owner, and output your lab needs.
Book a Free Consultation

“Prove this sample’s history.”

“Who approved this result?”

“Where is the validation evidence?”

“What changed since qualification?”

“Prove this sample’s history.”

“Who approved this result?”

“Where is the validation evidence?”

“What changed since qualification?”

Chosen by labs that set the standard

Scispot stayed close to the technical details and extended label printing across our device environment. That makes the clinical workflow easier for the team to use and showed that the delivery team would stay with the practical issues that matter in day-to-day operations.
Ally Hirsch
Scientist & Regulatory Technical Lead
Our team was spending too much time on sample tracking and spreadsheet gymnastics instead of the science. Scispot is becoming the single place we can answer what happened to a sample, from intake through capture, libraries, and sequencing.
Brett Stevens
Director of Translational Laboratory Research
Scispot gave our Medical Affairs team a practical way to collect PHI-aware patient submissions and test requests while keeping the lab workflow connected to Sample Manager
Dr. Onome Braimah
Head Medical Affairs
Our team needed a system that allowed for more flexibility while keeping data for our sample intake and processing current. Scispot worked closely with us through recurring sessions to shape a more manageable system using custom automations and also determine best next steps for workflow improvement.
Emily Reister, PhD
Staff Laboratory Science Lead