Systech Publishes Comprehensive Resources Guide to DSCSA
Industry Leader Combines Tools and Information for Rapid Compliance
PRINCETON, NJ – (June 28, 2017) – Systech International, a global technology solutions leader and innovator in serialization, traceability and brand protection, announces a unique resource guide to assist pharmaceutical companies in meeting the des Gesetzes zur Sicherheit der Arzneimittelversorgungskette (DSCSA) an die erweiterte Sicherheit des Arzneimittelvertriebs by the November 27, 2017 deadline. While most of the largest global pharmaceutical manufacturers are underway with compliance efforts, many mid-tier manufacturers, CMOs, CPOs, and virtual pharmaceutical companies are racing to meet the deadline.
Systech’s in-house regulatory expert, Dirk Rodgers, has compiled an essential resource guide to help companies understand and meet the DSCSA requirements, without sifting through outdated or incorrect information. In total, Systech’s resource guide is the most comprehensive DSCSA document available today. The guide includes links to:
- Food and Drug Administration (FDA): Full text of the DSCSA, FDA guidance, webinars, Q&A documents and planning documents
- The Healthcare Distribution Alliance (HDA): Barcode guidance, explanations of all DSCSA data exchange scenarios, guidance for using EDI, solutions to the 2019 saleable returns problem, and solutions to the master data exchange problem
- GS1 Healthcare: Explanation of the technology behind the interoperable exchange of data within a supply chain that uses GS1 standards
- RxTrace: Dozens of articles that simplify and explain DSCSA concepts and technologies needed to meet requirements
As the worldwide industry leader in pharmaceutical serialization, Systech’s resource guide can be combined with its previously released “Serialized by November” program to enable customers to meet the minimum regulatory requirements by the November 2017 deadline. Systech’s hardware-agnostic serialization software minimizes downtime on a packaging line—without having to change platforms or purchase additional software or licenses.
To access Systech’s free guide, download it here. To learn more or to get assistance with your serialization requirements check out Systech’s “Serialized by November” program or contact Systech.