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Life Sciences · Pharmaceutical Quality Control

PharmaVision QC

A vendor-neutral, grounded decision layer that fuses machine vision, analytical chemistry, label identity and AI into one auditable release decision — see everything, trust the decision, prove it to the auditor.

4→1
signals to one decision
Provable
false-accept bound
Annex 22
AI-readiness built in
Open
drivers only, no lock-in
AI defect detection with corroborated verdicts and a grounded decision panel
Overview

One layer over the hardware and systems you already trust

PharmaVision QC is not another camera, spectrometer, LIMS, MES or QMS. It is the neutral decision, guarantee and governance layer that sits above them — fusing every quality signal into a single grounded, signed disposition, with every source surfaced side by side so nothing is buried.

The rule is simple and safe: physics > chemistry > identity > AI. Artificial intelligence may only raise rigor — it can never overrule the hard scientific evidence — and every attempt to relax a decision is recorded.

Core Capabilities

What PharmaVision QC delivers

Vision inspection

Pixel-level defect detection, sub-pixel measurement and a costed AQL disposition — on any open-standard camera.

Analytical chemistry

NIR / Raman / FTIR identity, HPLC impurities (ICH), polymorph and a one-click Spectral Purity Index.

Unified authenticity

Fuses vision, chemistry, label and AI into one corroborated verdict; conflicts are surfaced, not hidden.

Adulterant & counterfeit scan

Localises unexpected spectral peaks from a single genuine reference — pinpoints where the problem is.

Changeover (MACO) risk

Health-based cross-contamination risk on shared equipment (EMA / ISPE Risk-MaPP), with cleaning guidance.

Provable escape bound

A conformal, distribution-free limit on false-accepts — a guarantee that gates release, not just a score.

Grounded AI Studio

Train your own model or load a third-party one; both are grounded, attested and validated with real ROC.

Governance & audit

Hash-chained audit, e-signatures, ALCOA+ integrity, Annex 22 AI-readiness and a Quality Risk Index.

Open, on-prem, secure

Open-source drivers only; on-prem-first; local LLM on site; cloud AI strictly opt-in and data-sovereign.

How it works

From raw signal to a defensible release decision

Capture Analyse Verify vs physics Fuse sources Ground (AI advisory) Decide Prove
Seeing is believing

Real quality intelligence

Vendor-neutral by design

One platform, any modality — open drivers, no lock-in

Connect over open standards and reach the same hardware without proprietary SDKs. Proprietary vendor SDKs are deliberately set aside.

GenICam / Aravis V4L2 / UVC GStreamer NIR / Raman / FTIR HPLC / LC-MS (JCAMP · mzML · CSV) OPC UA · Modbus · MQTT DICOM
Who it's for

Built for the teams that release the product

QA / QC and release teams, analytical and PAT scientists, validation and CSV engineers, manufacturing-science & technology (MSAT), CDMOs and generics manufacturers, and inspectors across FDA, EU, MHRA, PIC/S and WHO-GMP markets.

Key Benefits

Outcomes you can measure

One grounded decision, not many conflicting checks
Fewer escaped defects and recalls
Earlier counterfeit & adulteration detection
Less scrap from over-rejection
Auditor-ready evidence on demand
Safe, governed AI in a GxP context
Global regulated markets

Designed for the frameworks buyers cite worldwide

US FDA 21 CFR Part 11 EU GMP Annex 11 EU Annex 22 (AI) UK MHRA PIC/S WHO-GMP GAMP 5
Product Preview

Inside PharmaVision QC

A look at the workspace — executive dashboards, in-product model validation and changeover risk in one place.

PharmaVision QC executive dashboard preview
Per-product ROC — cross-validated in-product model validation
Health-based changeover (MACO) risk assessment
PharmaVision QC is at pilot readiness (TRL 4–5). The built-in trainer already produces real cross-validated ROC on your labelled data; independent method validation on representative, product-specific data is the recommended next step before GxP release use.

See PharmaVision QC in action

Talk to our team about an advisory or parallel-run pilot tailored to your site and products.

Talk to Sales
Standards & engineering alignment

Fits your compliance environment

PharmaVision QC is designed to support the quality and data-integrity standards that govern pharmaceutical manufacturing.

EU GMP Annex 11

Computerised systems

Supports audit trails, access control and data integrity expectations.

FDA 21 CFR Part 11

Electronic records

Signed, tamper-evident records aligned to electronic-records practice.

ALCOA+

Data integrity

Every result attributable, legible, contemporaneous and traceable.

ISO/IEC 27001

Information security

Deployable inside a validated, secured environment.

Designed to support and align with the frameworks above. Alignment describes how the platform fits your program; it is not a claim of independent certification unless separately stated.

Built for your scale

From a single team to the whole enterprise

PharmaVision QC is designed to deliver value on day one for a small team, and to scale to a governed, multi-site enterprise deployment on the same platform.

For growing & mid-size businesses

Inspection-grade QC for a single production line
Clear release/hold verdicts with the evidence attached
Deploy inside your validated environment
Actionable findings for QA operators

For large organizations

Standardized QC across every line and site
Audit-ready, governed records for GMP environments
On-prem or private-cloud with full data sovereignty
Systemic detection across batches and sites
In practice

Deployment scenarios

Illustrative walkthroughs of how PharmaVision QC is used and the value it creates. Your figures are set on your own data during a proof-of-value engagement.

Batch release decision

A batch trending toward a specification limit is flagged with the evidence, supporting a defensible release/hold call.

Audit-ready records

Every disposition leaves a signed, tamper-evident record for inspection.

Multi-site standard

Every site applies the same grounded standard, comparable across the network.

Proof of value

See it on your own data

A scoped engagement shows the results measured on your own operation before any wide rollout — then scale across the organization on the same platform.

Book a proof of value