SAP unveils pharma serialization suite

Enterprise software company SAP has launched its dedicated track-and-trace suite for pharmaceutical companies that need to meet serialization mandates.

The company says it worked with "leading pharmaceutical and wholesale companies to develop a track-and-trace solution that meets and exceeds" those regulatory requirements, including country-specific reporting and close integration with supply chain partners such as contract manufacturers, packagers and third-party logistics (3PL) companies.

The platform has also been created with an eye on integrating the serialization functionality with warehouse management, according to SAP.

The new dedicated suite - called Advanced Track and Trace for Pharmaceuticals (ATTP) has been designed from the ground up and will sit alongside older modules used for coding and scanning applications such as SAP's Auto-ID Infrastructure (Aii), Object Event Repository (OER).

The latter will be retained and supported, although SAP hopes customers will migrate to the new platform and has built tools to assist in that process.

SAP is the largest enterprise-resource planning (ERP) software company in the world according to Gartner data - ahead of rivals Oracle, Sage, Infor and Microsoft - so the launch of the new product is expected to make waves in the track-and-trace market.

The text of the press release follows:

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SAP supports compliance with global serialization regulations, helps fight drug counterfeits

SAP has announced the launch of the SAP Advanced Track and Trace for Pharmaceuticals application, focused on supporting the pharmaceutical industry in complying with global serialization requirements. These requirements include identifying each drug package with a unique and randomized serial number according to country-specific guidelines and reporting it to the authorities. With this new application, SAP is helping the pharmaceutical industry maintain the safety and security of drugs as they move across the worldwide value chain through the ability to identify and reduce drug counterfeiting opportunities.

Counterfeit prescription drugs introduced into the legitimate drug value chain have been a growing worldwide problem that directly impacts public safety. Governments and manufacturers have taken steps to address the problem with a series of measures. Recent legislation in the EU, US and numerous other countries has unavoidably increased the complexity of business processes required to comply with such diverse global regulations.

SAP worked with leading pharmaceutical and wholesale companies to develop a track-and-trace solution that meets and exceeds global serialization regulatory requirements. SAP Advanced Track and Trace for Pharmaceuticals includes country-specific reporting, enhanced collaboration with contract manufacturers and packagers and tighter integration with warehouse management and manufacturing solutions. The application also features extended serial number management capabilities as well as a high-performance electronic product code information services (EPCIS) repository to address the massive amount of data generated from the vast number of product items and processing stages.

SAP and its customers recognize that both the complexity and the cost of applying a serial number to an individual drug package is compounded by maintaining and communicating that information electronically up and down the value chain. SAP Advanced Track and Trace for Pharmaceuticals offers global pharmaceutical companies the ability to generate, manage and transmit serial numbers to help ensure the safety and security of drugs while also maintaining compliance with global regulations.

Companies can use the application to manage the large amount of serialized event data while also providing and maintaining country-specific reporting as a key solution differentiator. The application utilizes an open architecture and integration framework to easily integrate SAP and non-SAP solutions in track-and-trace business processes.

"Governments globally are working to protect patients from counterfeit versions of life-saving products in situations where the patient's outcome could be, at best, an adverse reaction to a poorly manufactured product or, at worst, a fatality given the patient is not taking the prescribed drug for a specific therapeutic condition," said Joe Miles, global vice president, Industry Business Unit Life Sciences, SAP.

"To help ensure we will be able to comply with regulations aiming at delivering safe medicines to patients, we went on a very exciting journey together with one team of SAP experts and industry representatives collaborating toward the same goal," said Stephane Aubert, director of IT, Serialization Program & CMO Integration, UCB BioPharma. "With SAP Advanced Track and Trace for Pharmaceuticals, we have a solution designed to fulfil our requirements."

Key features of SAP Advanced Track and Trace for Pharmaceuticals, available to customers today, include an advanced serial number management, including randomization; an EPCIS repository capable of handling huge data volumes; regulatory reporting for authorities and supply chain partners; and deep warehouse integration and activity validation.