Show QA what happened, not just what was rejected.
Fulcrym adds an independent inspection and evidence layer to legacy solid-dose lines. Start in parallel mode, preserve existing validation, and generate audit-ready outputs built for QA review and investigations.
The 30-second overview
Fulcrym captures inspection evidence, standardizes defect classification, and packages batch-ready outputs so QA can review, trend, and defend decisions without ripping out existing validated systems.
Inputs
Tablets/capsules being inspected or sampled, plus optional line signals and batch context.
Process
Evidence capture → defect taxonomy → QA review workflow → structured reporting.
Outputs
Batch evidence package, searchable defect library, and trend signals for drift and recurrence.
Where it sits
Start in the lowest disruption mode and graduate to deeper integration once value is proven.
Parallel mode (recommended start)
Run alongside the incumbent process to validate performance without impacting release decisions.
Line-adjacent deployment
Installed near the inspection point for high throughput while preserving the existing validated flow.
Offline / sampling mode
Ideal for early pilots or change-control sensitive environments, while still generating the same evidence outputs.
Validation and compliance positioning
Fulcrym is positioned as decision support and evidence generation. QA retains authority and review control.
What we validate
Defect taxonomy configuration, throughput targets, audit trails, role-based access, and report reproducibility.
What it supports
Deviation investigations, OOS/OOT context, supplier conversations, continuous improvement, and audit defense.
Change-control friendly
Begin with parallel evidence generation and expand based on risk assessment and demonstrated value.
What a pilot looks like
A practical rollout designed to move through site governance without drama.
Weeks 0–1
Discovery: intended use, success criteria, and validation scope.
Weeks 2–3
Install & configure: evidence capture + defect taxonomy alignment.
Weeks 4–6
Parallel run: compare to incumbent workflow and document results.
Weeks 7–8
Readout: pilot report including defect breakdown, false reject analysis, and ROI projection.
What you provide
Line access windows, sample runs, and a QA point-person for review workflow alignment.
What Fulcrym provides
Deployment, training, SOP templates, evidence reporting pack, and final pilot report.
Data integrity and security
Short, confidence-building, and aligned to how quality teams actually operate.
Access control
Role-based access aligned to QA review responsibilities.
Audit trails
Review actions are traceable to users and time, supporting investigations and audits.
Retention
Retention policies configurable to site requirements and governance.
FAQ
Answers to the objections that show up in the first five minutes of a serious conversation.
Does this replace our current vision system?
Does Fulcrym make release decisions?
How disruptive is installation?
What do we receive at the end of a pilot?
Can this scale across multiple products or sites?
Ready to see it on your product?
We’ll walk through intended use, pilot scope, and the validation path that fits your site governance.