Surface what matters in GxP review.
XceptionIQ helps QA teams review structured and unstructured evidence across audit trails, SOPs, logs, forms, workflow exports, training records, calibration history, and final report packages.
Candidate findings stay linked to evidence. QA stays in control.
Why We Exist
GxP review is rarely contained in one system or one audit trail.
QA teams often reconcile instrument logs, manual templates, raw data notes, workflow timestamps, SOP requirements, user access, training status, calibration records, and final report appendices across disconnected files.
The work is repetitive, evidence is fragmented, and the risk is not just a missed anomaly. It is missed context, unclear rationale, and extra audit exposure when reviewers have to stitch everything together by hand.
“Audit trails matter. So do the forms, roles, SOPs, workflow gates, and records around them.”
Evidence is scattered across packages
A reviewer may need audit trails, signed forms, workflow exports, training matrices, and calibration logs to decide whether one activity was acceptable.
Missing context hides the real issue
A timestamp only becomes meaningful when it is compared to SOP sequencing, user authorization, training completion, and equipment status.
Final reports need defensible rationale
When an auditor asks how an issue was identified, the answer needs linked evidence, a review rule, and a documented human disposition.
Hybrid workflows are the norm
Small and mid-sized regulated teams rarely have perfect system integration. They rely on uploads, exports, scanned records, and templates.
Evidence Types
Built for real-world GxP evidence packages
Bring the audit trails, forms, exports, and supporting records you already have. XceptionIQ reviews the evidence package as it exists.
Instrument audit trails
Analyzer logs, run reports, event histories, and born-digital exports.
Manual templates and logs
Equipment-use logs, worksheets, batch records, and sample processing forms.
Scanned and archived records
Signed paper forms, archived logs, scanned attachments, and supporting PDFs.
Workflow exports
LIMS, ELN, QMS, workflow tools, tickets, card histories, and timestamps.
SOPs and procedures
Review procedures, execution steps, evidence requirements, and approval rules.
Role and training records
User-role matrices, training completion, authorization lists, and temporary access.
Calibration and maintenance
Calibration certificates, PM logs, status records, and out-of-service history.
Final report packages
Raw data indexes, appendix lists, report references, and client-ready outputs.
How It Works
AI proposes. Humans decide. Every step is defensible.
XceptionIQ turns mixed evidence packages into review-ready candidate findings with linked evidence, explainable checks, and a documented human decision.
Ingest the evidence package
Upload audit trails, SOPs, templates, scanned forms, calibration records, training data, workflow exports, and final report artifacts.
Normalize the evidence
Convert each artifact into a common model of studies, runs, instruments, users, roles, timestamps, files, and required records.
Apply SOP-derived checks
Check completeness, sequencing, role authorization, training status, calibration status, missing records, and deviations against your rules.
Surface candidate findings
Highlight issues that need attention and show the exact source evidence and rationale behind each surfaced item.
Keep QA in control
Reviewers accept, reject, clear, edit, or escalate each item and record the human rationale that belongs in the review history.
Generate a traceable report
Export a reviewer-approved package for internal QA, sponsor audits, client review, or inspection readiness.
Candidate Findings
Concrete checks reviewers can evaluate quickly
XceptionIQ is most useful when it turns cross-document review work into explicit candidate findings with source evidence already assembled.
Required instrument-use template is missing
Evidence compared: SOP + workflow step + uploaded forms
Activity performed by a user without matching role authorization
Evidence compared: User-role matrix + activity log
Activity occurred before required training completion
Evidence compared: Training record + timestamped event
Instrument used outside calibration or maintenance window
Evidence compared: Run timestamp + calibration record
Workflow advanced before required raw data was attached
Evidence compared: Workflow export + required evidence list
Final report reference has no matching usage or scanning record
Evidence compared: Appendix reference + usage log
SOP-required field is blank or inconsistent
Evidence compared: SOP + scanned or template form
Event sequence does not match approved procedure
Evidence compared: SOP + timestamps + workflow history
Trust and Controls
Designed to support regulated review workflows
XceptionIQ does not replace QA judgment and does not make compliance decisions automatically. It prepares evidence, applies configured checks, explains why an item was surfaced, and records how the reviewer handled it.
Customers remain responsible for their SOPs, validation approach, intended use, and final QA decisions. XceptionIQ supports those workflows with traceability, evidence links, reviewer disposition, and versioned rules.
QA remains the decision-maker
Every surfaced item is a candidate finding that requires human review, rationale, and approval before it appears in a final report.
Traceable review history
Reviewer disposition, rule versions, linked evidence, and approval history stay attached to the review package for inspection readiness.
Configurable SOP-derived checks
Checks are aligned to your review procedures and evidence requirements rather than a fixed one-size-fits-all compliance template.
Built For
Every role in your QA chain of custody
XceptionIQ is built for the teams who review, govern, approve, and support recurring GxP evidence packages across instruments, documents, and SOPs.
QA Reviewer
- Fast triage of recurring evidence packages
- Linked evidence for every candidate finding
- Confirm, clear, edit, and escalate controls
- Reviewer rationale captured in one place
QA Manager / Supervisor
- Dashboard of open and verified findings
- Trend visibility across studies, users, and instruments
- Approval gates for higher-risk items
- Reviewer-ready final report sign-off
Compliance / CSV Lead
- SOP-derived checks and governed rule sets
- Versioned prompts, models, and evidence logic
- Traceable reviewer disposition history
- Validation-ready control and audit context
System Administrator
- Role-based access control
- Evidence intake and connector configuration
- Workflow governance and account support
- Monitoring and operational oversight
Best-Fit Environments
Built for recurring GxP review workflows across regulated lab and quality teams.
Contract analytical labs
Recurring study packages with manual review overhead and sponsor-facing QA expectations.
GxP service teams
Hybrid evidence that spans study records, forms, workflow gates, and report appendices.
Pharma and biotech QC
Evidence review across instruments, SOPs, training records, and equipment status.
Inspection readiness teams
Groups preparing defensible evidence packages for internal QA, clients, or inspectors.
Review Coverage
One review experience across hybrid evidence sources
Bring us a representative evidence package.
We'll show you how XceptionIQ can review audit trails, forms, workflow records, SOPs, training data, calibration evidence, and report artifacts in one QA flow.
Bring your own evidence first. Add integrations where they reduce recurring effort.