PRINCETON, N.J., June 28, 2017 /PRNewswire/ -- 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 Drug Supply Chain Security Act (DSCSA) 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an essential resource guide to help companies understand and meet the DSCSA requirements, without sifting through outdated or incorrect information.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 deadline. Systech's hardware-agnostic serialization software minimizes downtime on a packaging line—without having to change platforms or purchase additional software or licenses.
About Systech International
As the innovator of serialization, Systech is trusted by top pharmaceutical companies worldwide to ensure regulatory compliance, mitigate risk, ensure supply chain integrity, and drive efficiency. Beyond compliance, the company is leading the charge to protect global brands—for consumer packaged goods, food & beverage, health & beauty, pharmaceutical, and contract manufacturing companies. Its best practices and award-winning technologies are guiding Product and Brand Protection Officers in their quest to improve patient/consumer safety, increase engagement, decrease counterfeiting, avoid diversion, and reduce harm to coveted brands.
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SOURCE Systech International