Solving
Track and Trace
Together
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.
The Advasur 360 Application Suite
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
Together
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
Be Sure With Advasur
Our services solution provides dispensers with full current DSCSA compliance as well as a roadmap to the upcoming Enhanced Drug Distribution Security (EDDS) support necessary for full mandate requirements for the November 27, 2023 deadline.
Advasur’s DQSA/DSCSA
Compliance and Audit Services
Broken Down Into Three Groups
DQSA Repository Services:
Application Solution Providers (ASPs) focus on pharmaceutical manufacturers and/or wholesalers and provide software to limited shipping notice transmission services. To date, Advasur has not found ASP service providers that perform validation of the transmitted shipping notice data or audit the data while in transmission. Also, the ASP providers who service the pharmaceutical manufacturers may have conflicts with wholesaler customers who are Authorized Distributors of Record (ADR) for those manufacturers.
Both manufacturer- and wholesaler-led trading associations have expressed concern about costs of DSCSA implementation and may intend to push costs down to the pharmacy level. Advasur is owned by pharmacists who are focused on building DQSA compliance systems in the best interests of pharmacists and the patients they serve. Advasur has no conflict when adjudicating DQSA discrepancies between trading partners, as Advasur only has one client, the pharmacist!
Prime Vendor and Direct Generic Manufacturer DSCSA Compliance Services:
Advasur has developed a Harmonized Product Code (HPC) system to correlate serialized and non-serialized drug products. The Advasur HPC was designed to accommodate and synchronize the 9 serialization schemas used in over 30 countries.
DQSA Repository Services:
Advasur 360 audits wholesalers exclusively for pharmacies and performs audits for new manufacturer suppliers for pharmacies. These two types of audits provide in depth knowledge of other trading partners to ensure pharmacy adjudication issues are addressed fairly by other trading partners through which they are supplied.