Pharmaceuticals
Item-level serialization, GxP audit trails, and cold-chain integrity from manufacture to dispense.
Map a control once. Cite it everywhere.
What teams do with Traceage
Every card is a real job, framed for the person who owns it.
QA Manager
Inspection-ready batch records
Every CCP reading, deviation, and CAPA timestamped and signed — auditors get a clean trail, not a fire drill.
Qualified Person
Confident batch release
Review and certify batch disposition against the full genealogy before release, e-signature on the record.
Serialization Lead
DSCSA & EU FMD serialization
SGTIN item-level serialization and transaction history on one platform — no parallel track-and-trace system.
Cold-chain Manager
Excursion-driven holds
Temperature breaks trigger automatic holds and root-cause event chains, not just SMS alerts.
Regulatory Affairs Manager
Market-ready submissions
Format-native dossiers and variations for every market the product ships to, from one record.
Supply Chain Director
Upstream API visibility
Trace finished product back through every active-ingredient and excipient supplier, tier by tier.
Every stage on one continuous record.
The pharmaceuticalsworkflow — and where Traceage fits at each step.
- 01
Source & receive
APIs and excipients logged at intake with supplier and certificate of analysis.
- 02
Manufacture & release
Batch records, in-process checks, and Qualified Person release on one trail.
- 03
Serialize
SGTIN item-level codes applied; EPCIS commissioning events captured.
- 04
Distribute
Cold-chain custody and transaction history tracked leg by leg.
- 05
Dispense & verify
Pharmacy and hospital scans confirm authenticity before the patient.
What it delivers.
Proof of authenticity & quality
Every pack serialized and verifiable from line to patient.
Verified ethical & sustainable sourcing
Each API and excipient traced to a qualified, audited source.
Real-time visibility & convenience
Wholesalers and pharmacies confirm a product's history in one scan.
Fast, painless issue resolution
A suspect lot is isolated before it ever reaches a patient.
The regulations, in plain terms.
Every framework Traceage maps for pharmaceuticals.
- GMP
- Good Manufacturing Practice — the production and quality controls that keep regulated goods made consistently and safely.
- ICH Q7-Q10
- International Council for Harmonisation guidelines Q7-Q10 — good practice for active ingredients, pharmaceutical development, quality systems, and risk management.
- DSCSA
- US Drug Supply Chain Security Act — item-level serialization and transaction history for prescription drugs.
- EU FMD
- EU Falsified Medicines Directive — safety features and verification that keep counterfeit medicines out of the supply chain.
- 21 CFR Part 11
- Title 21 of the US Code of Federal Regulations, Part 11 — the FDA rule governing electronic records and electronic signatures.
- EMA
- European Medicines Agency — the EU authority for the evaluation and supervision of medicines.
See it on your own data.
Stand up a working setup in days. No rip-and-replace.