Enterprise quality management

Every audit. Every supplier. One record.

SmartHawk runs your quality system and every audit you conduct, host or run on yourself — so supplier qualification updates itself from audit outcomes.

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Audit register

AuditsSuppliersFindingsCAPADocuments

Reference	Type	Subject	Phase	Risk
AUD-2417	API Site Audit · ICH Q7	Sanpras Labs	Reporting	High
AUD-2416	Finished Product · CMO	Verdant Pharma	Closed	Low
AUD-2415	Internal Self-Inspection	Site 2 · Hyderabad	Execution	Medium
AUD-2413	Regulatory Inspection	Hosted · CDSCO	Prepared	Low

Illustrative. Audit types, phases and risk bands are the platform's own.

Twelve: canonical audit types
Four: deployment models
Part 11: e-signature enforced
US · EU: data residency

The name

SMART is what the platform does

Five steps every regulated record moves through, in order.

Sense

Evidence, responses and regulatory signal captured as they appear.

Monitor

Every audit, CAPA and supplier tracked live by phase, owner and risk.

Analyze

Risk scored in code; findings drafted with every claim cited.

Record

E-signature and a hash-sealed trail on every regulated change.

Trace

Any record followed across modules and years, in seconds.

What only we do

Three audits, one object

Regulators require all three; everyone else built for one.

Audits you run

Supplier and contract-site audits, against your own audit types.

Audits you host

Regulatory inspections and customer audits of your own sites.

Audits on yourself

Self-inspection, on the engine that runs the other two.

One finding closes the same way whoever raised it.

The platform

Three modules over one compliance engine

Modules are enabled per tenant. The record underneath them is shared.

Audit Management

Core

Every audit you conduct, host, or run on yourself.

Audit programmes
Audit execution
Checklist libraries
Findings & CAPA
Auditor qualification
Audit RFQ

Supplier Management

Core

Qualification and requalification as live state.

Pre-qualification
Approved supplier list
Sites & materials
Quality agreements
Risk scorecards
Public signal

Enterprise Quality

Suite

The closed loop the audits feed into.

Deviations
CAPA
Change control
Document control
Training records
Complaints & OOS
Batch records
Equipment
Design control
Risk register
Management review
Audit trail

Built for regulated industries

Audit-ready by default

21 CFR Part 11: E-signature and audit trail enforced
EU GMP Annex 11: Computerised-systems controls
ISO 9001 · ISO 13485: Audit programmes out of the box
US and EU residency: Region chosen at contract

See the full compliance posture →

Start with one audit programme

Configured, not implemented. Weeks, not a capital budget.

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