MANUFACTURING & SUPPLY CHAIN COMPLIANCE

Late-cycle reconciliation is a symptom.

Late-cycle reconciliation
is a symptom.

The root cause is upstream evidence that never carried forward.


RegIQX connects supplier CoAs, batch records, and CAPA findings to regulatory submission on a single compliance backbone — so the evidence chain that

informed quality decisions is the same one that informs what gets filed.


The backbone is a shared rule library, citeable regulatory references, FIVES scoring, and a continuous audit trail — running from supply chain through

submission, not rebuilt at each handoff.

The root cause is upstream evidence that never carried forward.


RegIQX connects supplier CoAs, batch records, and CAPA findings to regulatory

submission on a single compliance backbone — so the evidence chain that

informed quality decisions is the same one that informs what gets filed.


The backbone is a shared rule library, citeable regulatory references, FIVES scoring,

and a continuous audit trail — running from supply chain through submission, not

rebuilt at each handoff.

The root cause is upstream evidence that never carried forward.


RegIQX connects supplier CoAs, batch records, and CAPA findings to regulatory submission on a single compliance

backbone — so the evidence chain that informed quality decisions is the same one that informs what gets filed.


The backbone is a shared rule library, citeable regulatory references, FIVES scoring, and a continuous audit trail

— running from supply chain through submission, not rebuilt at each handoff.

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Watch 10-min walkthrough →

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The Problem Worth Solving

Compliance breaks at handoffs

Supplier quality, batch records, CAPA, and submission teams run separate

tools with no shared rule model. Evidence is manually reconciled at every boundary.


Audit trails that stop at the plant

CoA exceptions and deviation findings rarely carry regulatory

citations forward. By the time an inspector asks, the original context is gone.


Submission rework that compounds late

Filing teams spend weeks reconciling manufacturing evidence that was never structured

for submission. Much of that cost is avoidable when evidence is organized at source.

Compliance breaks at handoffs

Supplier quality, batch records, CAPA, and submission teams run separate

tools with no shared rule model. Evidence is manually reconciled at every boundary.


Audit trails that stop at the plant

CoA exceptions and deviation findings rarely carry regulatory

citations forward. By the time an inspector asks, the original context is gone.


Submission rework that compounds late

Filing teams spend weeks reconciling manufacturing evidence that was never structured

for submission. Much of that cost is avoidable when evidence is organized at source.

Manufacturing Compliance — Shop Floor To Submission

Manufacturing Compliance —
Shop Floor To Submission

  1. INGEST

Suppliers & CoA signals

Ingest supplier documentation

attestations, and CoA data against

the shared rule library. Flags

exceptions with citations attached

— before they reach batch review.

Supply Chain Quality

Supplier quality leads

  1. EXTRACT & VALIDATE

Batch records & MBR validation

Extract and validate batch documents

against master batch records.

Human-in-the-loop review where it

matters. Carries rule codes and

regulatory context forward — usable

beyond the plant, not only for QA

sign-off.

Batch Document Intelligence

Manufacturing Intelligence

Manufacturing QA

  1. ROUTE & CLOSE

CAPA with regulatory routing

Route deviations with regulatory

context already attached. Close the

loop across functions.

Builds the audit trail continuously —

not reconstructed before inspection.

Corrective Action

Quality & Regulatory

  1. VALIDATE & PACKAGE

Submissions — incident to

FDA's inbox

The same rule library and citations

that governed quality decisions

govern submission checks: structured

validation, remediation export, and

inspection-ready output. Validates

against the agency standard without

rebuilding the compliance story from

scratch. Your validated publishing,

gateway, and dispatch procedures

remain yours — RegIQX aligns

evidence and checks to the same

rule model end to end.

Submissions

Regulatory operations

Business Outcomes — Who It Benefits

Business Outcomes —
Who It Benefits

SUPPLY CHAIN QUALITY

Fewer unresolved CoA exceptions

Risk signals and citations travel with

findings — not lost at the plant boundary

MANUFACTURING QA

Batch evidence structured for what follows

Rule codes and regulatory context

preserved for CAPA, audit, and filing

— not just QA release

REGULATORY OPERATIONS

Less late-cycle reconciliation

Manufacturing evidence already organized

against the submission rule model — much

of the rework does not happen

Automation without citeable rules is not defensible
in audit — and not useful in filing.


Five capability areas.
RegIQX is the Compliance Backbone
built into Manufacturing & Supply Chain.

Automation without citeable rules
is not defensible in audit
— and not useful in filing.


Five capability areas.
RegIQX is the Compliance
Backbone built into
Manufacturing & Supply Chain.

Compliance is infrastructure. Automation
without citeable rules is not defensible
in audit — and not useful in filing.


Five capability areas.
One compliance backbone.

Supply Chain Quality

Supplier quality, CoA workflows,

attestations, and risk signals — the

front of the compliance thread

Supplier quality, CoA workflows, attestations, and risk signals — the

front of the compliance thread

Batch Document Intelligence

Extraction, MBR validation, QA sign-off,

and batch-level signals

Manufacturing Intelligence

SPC, yield, equipment, OEE,

serialization — modular, on the same

rules engine

SPC, yield, equipment, OEE, serialization — modular, on the same

rules engine

Corrective Action

Deviation to closure with regulatory

context and a continuous audit trail

One platform, Evidence to filing

Evidence to filing on the same

compliance backbone. Agency

submission and gateway processes

remain your validated procedures.

Evidence to filing on the same compliance backbone. Agency

submission and gateway processes remain your validated procedures.

Evidence to filing on the same compliance

backbone. Agency submission and gateway

processes remain your validated procedures.

Frequently Asked Questions

What is RegIQX?

RegIQX is TFives’ compliance backbone for pharmaceutical manufacturing and supply chain. It connects supplier quality, batch records, CAPA and submission checks on one shared rule library with a continuous audit trail.

Does RegIQX submit to the FDA?

No. Your validated publishing, gateway and dispatch procedures stay yours. RegIQX validates evidence against the same rules used for quality decisions, so what you file is consistent and inspection-ready.

Does RegIQX replace our QMS or MES?

No. RegIQX works beside your existing systems and carries rule codes and regulatory citations from the shop floor through to submission.

See The Thread On Your Roadmap

See The Thread On
Your Roadmap

We’ll walk through how RegIQX connects the compliance evidence you’re already generating — from suppliers

and the shop floor — to what gets filed. No pitch deck: bring your current stack and we’ll map it.

We’ll walk through how RegIQX connects the compliance evidence you’re already

generating — from suppliers and the shop floor — to what gets filed.

No pitch deck: bring your current stack and we’ll map it.

Request a Conversation →

Request a Conversation →

Watch 10-min walkthrough →

Watch 10-min walkthrough →