The Drug Supply Chain Security Act (DSCSA) mandates that electronic serialization (eSerialization) be in place by November 2018 and unit level traceability by 2023. Regulatory bodies around the world—including those in the United States and Europe—are pushing the industry toward unit level serialization of drug products. Several countries, including Turkey, India, Italy, and China already require serialization on various levels of pharmaceutical packaging. For the pharmaceutical industry, eSerialization is a huge change from lot level control.
Netorus™ eSerialization Management generates electronic records in xml format suitable for export and in human-readable and printable document format. Multiple record formats are supported and the layout is easily tailored to support evolving regulatory requirements and company-specific formats and graphics such as logos.
Netorus™ eSerialization Management supports the import of serial data from your ERP, WMS or other transaction processing system.
Equally important to tracking product in the supply chain is the need to track data internally. Audit trail capability aids in complying with 21 CFR Part 11 requirements. Using the Audit Trail History interface, an administrative user can check on changes made to the system using the query function to search either the user who made the changes, the business object changed, changes made during a specific date range, or a combination of all of the above. The query results can then be exported for further analysis.
Netorus™ has the solution to FDA product tracing requirement.
All pharmaceutical and nutraceutical finished product is traceable by Netorus™ proprietary cloud-based eSerialization platform, including the QR code, the software and hardware.
Netorus™ eSerialization advantage:
- Original patented technology, used by competitors
- Current updated technology under patent pending review
- US FDA, EDQM, CFDA audited and validated from 2013
- Competitive Price
- Complete turn-key platform
- It`s a proprietary software program that no competitors can match