TransGenie gives pharmaceutical manufacturers, distributors, and pharmacies a clear and connected view of every batch from packaging to patient. With our pharmaceutical traceability software, quickly trace where the product came from, where it went, and what happened along the way without going through spreadsheets.
Get a walkthrough of how TransGenie tracks your products from packaging to patient.
Want to get a better grasp of pharmaceutical traceability? Here’s a quick look at what it means, how it fits, and why it matters.
Pharmaceutical traceability is a process of tracking each drug product across manufacturing, packaging, warehousing, distribution, and dispensing. During the process, every movement is recorded, so you can trace a single pack or the entire batch when you need it.
Many companies still piece together traceability data from ERP exports, courier records, and paperwork. When an actual recall happens, finding the right information becomes a scramble. Pharmaceutical traceability software replaces this by bringing all data into one searchable record.
With pharmaceutical traceability software by their side, quality teams can stay audit-ready, supply chain teams can see where the products are, and manufacturing teams can connect serialization data from the packaging line.
In 2026, falsified and diverted medicines are a documented problem worldwide, while regulators are setting clear traceability requirements for pharma companies. The WHO has estimated that about 1 in 10 medical products in low- and mid-income countries are substandard or falsified.
In the US, the Drug Supply Chain Security Act (DSCSA) requires electronic interoperability tracing across the pharmaceutical supply chain. Meanwhile, in the EU, the Falsified Medicines Directive (FMD) requires prescription medicines to carry a unique identifier and tamper-evident features.
However, traceability goes beyond compliance. When a product issue occurs, pharmaceutical traceability software helps teams quickly identify the affected lots and delivery points instead of pulling everything from the market.
Pharmaceutical traceability starts with product serialization, then links units to cases and pallets, tracks movement across facilities, and verifies each scan. TransGenie connects these records so teams can trace products by batch, case, or serial number
Give every saleable unit a unique 2D barcode containing its product ID, batch, expiry, and serial number.
Connect individual units to cases and pallets, so one scan can identify everything that’s packed inside.
Record each handoff as products move between facilities, warehouses, distributors, and pharmacies.
Check the product information at each scan and flag invalid or unexpected activity for review.
Search a batch, case, or serial number to see its linked history and identify the affected products quickly.
See how serialization, scanning, and tracking fit into your existing packaging line.
Look for lot and batch tracking, serialization, packaging hierarchy, compliance workflows, recall management, and system integration. TransGenie brings these capabilities together to connect product records across the pharmaceutical supply chain.
Generate, assign, search, and manage unique serial numbers for products, cases, and pallets from a single place.
View and manage the relationship between individual units, cases, and pallets as products are packaged and prepared.
Manage the required traceability data for US and EU markets with compliance rules, records, and reporting tools built-in. Thus, teams maintain the required product and verification information across markets
Create recall cases, identify the affected products, track recall activity, and keep the response organized from start to finish.
View the temperature and humidity readings alongside shipment information and quickly spot conditions falling outside limits.
Lot and batch tracking improves pharmaceutical quality control by linking product history across production and distribution. TransGenie keeps batch and lot records connected for faster issue investigation.
TransGenie connects your ERP, scanners, and packaging systems so product & traceability data can move between your existing tools without disrupting established workflows.
Monitor product activity and important updates from a single dashboard, with alerts when something needs attention.
TransGenie’s pharmaceutical traceability software brings the right tools into one place, so that each team can work with the product information they need.
Manage serialization, packaging data, and market-specific requirements from one system while keeping the production records organized.
Check the incoming product information, manage inventory data, and quickly spot mismatches before they turn into bigger issues.
Inspect the product status before dispensing and keep a clear record of medicines received, stored, and supplied to patients.
Find the record and product details needed for audits, investigations, and compliance reviews without manual data gathering.
Pharmaceutical traceability supports regulatory compliance by maintaining the product, serialization, verification, & movement records required across the supply chain. TransGenie helps teams organize these records for DSCSA, EU FMD, GS1, and GDP requirements.
Electronic, interoperable tracing and verification of prescription drugs at the package level.
Unique product identification and tamper-evident packaging with verification before dispensing.
Standardized identifiers, barcodes, and data formats for consistent information exchange.
Documented, controlled handling of medicines across storage and distribution activities.
Pharmaceutical traceability tracks medicines through manufacturing, packaging, distribution, and delivery. It helps businesses maintain accurate product records while supporting recalls, compliance, and supply chain visibility. Similar identification practices are also important when managing regulated medical products. Learn how identification and traceability in the medical device industry supports product integrity and compliance.
Discover how identification and traceability redefine standards in medical device landscape. Stay informed on the latest advancements ensuring patient safety & regulatory compliance. Navigate the future of healthcare precision.
Read the guideOur Pharmaceutical traceability software helps prevent counterfeit and diverted medicines by verifying serialized products and flagging suspicious activity. Our software tracks product movement and scan history so teams can identify and investigate suspicious stock faster.
Every scan is matched against the product’s serialized identity. This helps catch duplicate or altered codes before the product moves forward.
If the same serial number pops up in different locations or anything else looks odd, our software flags it for your team to investigate.
View where the products are moving and identify the stock that ends up outside its intended market or distribution route.
When a product is flagged, your team can hold it at the point of detection instead of letting it continue through the supply chain.
Every flagged event is backed by scan history and location data. This gives your team a clear record of what happened and where.
Find out how verification and diversion tracking protect your supply chain.
Here are the practical changes that teams notice once traceability becomes a part of their everyday operations.
to isolate an affected batch and every location holding it during a recall.
instead of five different spreadsheets, replacing manual entry with automation.
counterfeit and diverted stock gets flagged at verification before reaching patients.
compliance reports pulled in a single search whenever an inspector asks anything.
Wondering why pharmaceutical companies are choosing TransGenie? Here’s a side-by-side look at what changes when you make the switch.
Connect with our team to see TransGenie mapped to your compliance and workflow needs.
Each unit gets a unique code at packaging, linked to its case and pallet. After scanning it using pharmaceutical serialization software, it records where it goes, creating a complete product journey.
It helps you trace each product through the supply chain, find affected units faster during a recall, and keep records ready for audits. A good pharmaceutical track and trace software helps identify suspicious or counterfeit products before they reach patients.
A basic drug tracking system only shows where a batch was shipped. Only a full traceability system tracks individual units and keeps a record of every scan.
You can still send and receive shipment and serialization data manually or through semi-automated methods. Once the partner is compliant, those exchanges can be automated.
The system flags the issue and holds the affected unit for review, stopping flawed data from moving further down the chain.
Yes. Most systems can store scans offline and sync them when the connection returns. Check the vendor’s offline storage limits before choosing a platform.
The auditors may ask for product history, chain-of-custody records, and verification data. A traceability system lets you find and export these records much quicker.
Yes. In most pharmaceutical supply chain software, a unit can be re-serialized or relinked when it’s repackaged for a new market, with the original history preserved, not erased.
The software checks whether the scanned units match their case or pallet. Any mismatch is immediately flagged before it causes problems downstream.
The levels describe how far the traceability data moves through the business. Level 3 connects packaging lines and captures serialization data. Whereas Level 4 and Level 5 systems bring data together across the company and extend visibility to external partners, respectively. Most drug traceability software buyers often need L4 or L5, not just L3
ERP systems can support compliance, but they do not replace pharmaceutical traceability workflows. TransGenie connects your ERP, scanners, and packaging systems with the product and compliance records you need.