Systech offers powerful serialization and traceability functionality to help you meet global pharmaceutical regulations.
Our proven software platform covers the full stack—from Level 1 to Level 5—for unbeatable ease of implementation and speed to compliance. Equipment-agnostic, configurable solutions give you flexibility to adapt to new regulations cost-effectively without customizing for every change, wherever you do business.
Compliance mandates data accuracy which mirrors the physical product movement from point of manufacture to point of dispense. Our complete solution enables seamless and secure data exchange for traceability throughout the entire supply chain. This—combined with the ability to connect with master data systems and regulatory databases—creates a compliant system of record for your products.
A timely example is the final DSCSA milestone which mandates the implementation of an electronic, interoperable system to trace prescription drug products at the package level by November 27, 2023. These Enhanced Drug Distribution Security Requirements impact the entire pharma supply chain ecosystem: manufacturers, distributors, dispensers, repackagers, 3PLs and their trading partners. Systech has you covered for DSCSA compliance, including our Verification Router Service (VRS) and Authorized Trading Partner (ATP) support.
The Falsified Medicines Directive (FMD) establishes a “system of repositories” that manufacturers need to connect to send product information and serial numbers that are being sent to member countries. When dispensing medicines now in the EU, pharmacists have a system to scan each medicine and validate its serial number from the repositories.