SAP Supports Compliance with Global Serialization Regulations, Helps Fight Drug Counterfeits


WALLDORF — SAP SE (NYSE: SAP) today 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 European Union, U.S. 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 Stéphane Aubert, director of IT, Serialization Program & CMO Integration, UCB BioPharma. “With SAP Advanced Track and Trace for Pharmaceuticals, we have a solution designed to fulfill 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.

For more information, visit the SAP News Center. Follow SAP on Twitter at @sapnews.

Media Contact:

Mat Small, +1 (610) 661-1000, m.small@sap.com, ET

Any statements contained in this document that are not historical facts are forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to SAP are intended to identify such forward-looking statements. SAP undertakes no obligation to publicly update or revise any forward-looking statements. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. The factors that could affect SAP’s future financial results are discussed more fully in SAP’s filings with the U.S. Securities and Exchange Commission (“SEC”), including SAP’s most recent Annual Report on Form 20-F filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates.
Photo: Shutterstock