Drug Supply Chain Safety Act Compliant Serialization with STEPLogic Trace

Safety of the Drug Supply

The safety of the drug supply is the number one focus for the pharmaceutical and life sciences industry.

Counterfeit, stolen or misdirected products can endanger the health and safety of patients.

With this problem dramatically increasing worldwide in recent years, the Drug Supply Chain Safety Act (DSCSA) was signed into law in 2013.

To comply with federal mandates, manufacturers, distributors, and retailers must be able to track, trace and report on the movement of prescription drugs and medical devices, throughout the supply chain.

STEPLogic Trace

STEPLogic Trace is a comprehensive solution that supports cradle to grave tracking within the distribution center.

Trace was designed to manage the aggregation of serial numbers in a parent-child relationship, creating efficiencies in managing the data without compromising quality.

The system has been audited and validated for FDA Part 11 compliance as well.

Additionally, Trace enables companies to record serialized drugs, aggregate them by a unit of measure, and then connect multiple systems, platforms, and trading partners to view the supply chain in its entirety.

Trace allows for the serialization of every type of transaction or can be configured to manage capture of serial numbers just on inbound and outbound transactions.

Webcast: Watch the Johnson & Johnson, Securing the Drug Supply Chain Webcast

STEPLogic Platform

With the unique capabilities of the STEPLogic platform, users can create apps, write scripts and run reports that enable companies to match the dynamically changing requirements of the DSCSA and other country mandates.

Because of the adaptability of the STEPLogic platform, Trace and can easily integrate with any WMS and applied to the operation in a manner that makes the most sense for you.

Trace is integrated with industry-leading repository systems like SAP ATTp and Tracelink, as well as with conveyor scanning and sorting systems.

DSCSA Serialization System that Provides End-to-End Track and Trace of Pharmaceuticals

Fully compliant with federal serialization requirements
Easily integrates with repository systems (SAP ATTp, TraceLink)
Serial number aggregation to four or more levels
Easy to personalize and configure to meet individual operations
Customize processes and reporting structure, using the innovative STEPLogic platform

DMLogic Announces Enhanced Capabilities in Serialization Solution

STEPLogic Trace offers unlimited levels of aggregation and advanced Oracle integration

“Keeping the customer’s needs in our forefront is the basis behind DMLogic”Lynn Dermott, senior vice president of products, DMLogic

Version 6.1.3 of STEPLogic Trace offers enhanced user capabilities including complete integration with CSV files allowing for order and SKU uploads eliminating the need for any manually entered data.

These new capabilities allow for easier transactions by seamlessly extracting order or SKU data from the customer’s WMS to import into STEPLogic Trace. Trace integrates into the customer’s repository system allowing for data to be transmitted to downstream partners.

Additionally, version 6.1.3 offers advanced Oracle database configurations. STEPLogic Trace allows for sophisticated queuing in Oracle to handle an advance RAC configuration.

RAC configuration using STEPLogic Trace will allow multiple databases to correspond and initiate automatically, a step that will be transparent to processing.

“As we continue to enhance STEPLogic Trace we continue to offer the user the personalization and customization for their unique distribution process while meeting all federal guidelines,” said Lynn Dermott, senior vice president of products, DMLogic, LLC.

“Keeping the customer’s needs in our forefront is the basis behind DMLogic; so we will continue to upgrade our products based on customer feedback and with a keen eye on improving the user experience at all times.”

The system enables companies to connect multiple systems, platforms, and trading partners to view the supply chain in its entirety.

STEPLogic Trace can be configured as an edge solution for inbound and outbound transaction only or for the serialization of every type of transaction through the distribution process.

Download the White Paper & Case Study Implementing a Serialization Project Post DSCSA

Related Papers & Case Studies

Implementing a Serialization Project Post DSCSA
These 3 papers; Implementing a Serialization Project Post DSCSA, Fighting Counterfeit Drugs, and Customer Success Stories, detail both what to do, and what not to do when it comes to the serialization of products in the drug supply chain. Download Now!

More DMLogic Resources