The Advasur 360 suite of applications has been market leader in Track & Trace functionality.
Our Advasur 360 Repository removes the burden of responsibilities for dispensers that have been mandated through DQSA and DSCSA guidelines.Advasur 360 Repository goes even further with robust ROI reporting, timely compliance reports emailed directly to the dispenser and simple to use audit capabilities.
Advasur 360 repository team maintains its commitment to ensure the best of the industry blend of easy to use software and compliance management.
Advasur is experienced in building FDA compliance systems. Our private sector experience includes auditing wholesalers for both manufacturers and retail pharmacy chains.
Advasur has the advantage of working for both the government and private sector on pharmaceutical product and product data supply chain integrity audits.
Advasur built these 4 Federal Government Systems:
CDC SPARx Supply Chain Visibility System
DoD Medical Asset Management System
NIH CRIS Interops & System Integration
FDA CDER ELIPS Labeling & Reporting System
REQUEST A DEMO
The Advasur 360 Application Suite
The Advasur 360 suite of applications has been market leader in Track & Trace functionality.
Our Advasur 360 Repository removes the burden of responsibilities for dispensers that have been mandated through DQSA and DSCSA guidelines.Advasur 360 Repository goes even further with robust ROI reporting, timely compliance reports emailed directly to the dispenser and simple to use audit capabilities.
Advasur 360 repository team maintains its commitment to ensure the best of the industry blend of easy to use software and compliance management.
Advasur is experienced in building FDA compliance systems. Our private sector experience includes auditing wholesalers for both manufacturers and retail pharmacy chains.
Advasur has the advantage of working for both the government and private sector on pharmaceutical product and product data supply chain integrity audits.
Advasur built these 4 Federal Government Systems:
CDC SPARx Supply Chain Visibility System
DoD Medical Asset Management System
NIH CRIS Interops & System Integration
FDA CDER ELIPS Labeling & Reporting System
REQUEST A DEMO
The Advasur 360 Application Suite
Working as a Team …
Customized DSCSA Compliance Standard Operating Procedures (SOPs).
Ongoing Validation and Authentication of Client’s Suppliers.
Automatic Suspicious Order and Fraud & Abuse Monitoring.
Create customized modules for ASNs.
Set Up ASN AS2 Connections and Maintaining Dynamic Supplier Database.
Inspection and Routine Auditing of Supplier ASN’s for Accuracy.
Validating ASNs as 3rd Party for Inspectors.
Aggregated and Facility Specific DSCSA Compliance Reports that are Standard and Customized.
On-Line and On-Phone Support during and after an inspection.
Together
Everything in One Place …
Advasur’s Advasur 360™ comprehensive suite of services support provides a “hands off” solution to assure Drug Supply Chain Security Act (DSCSA) compliance.
Advasur 360™ DSCSA compliance by enabling its clients to conveniently capture, validate, all Advance Ship Notices (ASNs) and maintain transactional documents (“T3”). including T3 documentation for borrowing, selling, and distributing to other trading partners for a minimum of 6 years, per DSCSA requirements.
Are You Ready for the Drug Supply Chain Security Act?
The Drug Supply Chain Security Act (DSCSA), also referred to as Track and Trace, outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). DSCSA is an FDA unfunded, multi-requirement Act that is being phased in over a 10-year period. The FDA began providing guidelines in 2013 and have been implementing several key requirements at various stages since 2014. These requirements, development of standards, and the system for product tracing will continue to be phased in through the November 27, 2023.
As of today, there are 7 requirements that are currently enacted by the FDA and 3 additional requirements referred to as Enhanced Drug Distribution Security (EDDS) that will be released over staggered timelines between early 2022 and November 27, 2022
