In 2013, Congress passed the Drug Supply Chain Security Act (DSCSA) to protect US citizens from counterfeit and harmful prescription drugs. The act outlines the need for manufacturers, repackagers, wholesalers, and dispensers to architect an electronic and interoperable system to track and trace prescription drugs.
DSCSA Readiness Assessments
Does your company need track and trace pedigree data to enable product protection?
We know this is a challenging time for many life science companies in feeling confident they are fully ready and aware of all guidance and standards, but it doesn’t have to be. Our DSCSA readiness assessment evaluates supply chain and track trace programs to identify any gaps in order to ensure readiness for FDA DSCSA deadlines.
DSCSA Readiness Assessment
Our assessment helps to point companies in the right direction and while not a legal advice document can be used to help guide complex discussions with your legal and regulatory counsel.
- Organizations understand of applicable regulations and guidances
- Product packaging serialization related barcodes and labeling
- Barcode scanning and data capture capabilities
- Data retention policies
- Serialization system and process benchmarking
- Tools and processes required to support planned or unplanned audits
- Identification of gaps in readiness
- Alignment with FDA, GS1 and HDA guidance and specification
- Identification of future value beyond compliance (ROI)