Experts in US DSCSA Regulations and DSCSA Compliance
Complex regulations. Costly enterprise software and systems not integrating. The Drug Supply Chain Security Act (DSCSA) has added another layer of complexity, and there’s no margin for error when it comes to compliance.
You have enough to worry about – we get it. That’s why we’ve developed the most comprehensive and automated solution to meet the stringent DSCSA requirements, yet flexible enough to support both lot level and unit and aggregated serialization.
There’s no need to go it alone. Choose the rfXcel US Compliance Management™ solution and rely on the experts at rfXcel to take the worry out of compliance!
Compliance should not be painful
Complying with regulations can be complex and stressful, but you’re covered with the rfXcel US Compliance Management (rCM) application. It is a comprehensive, end-to- end DSCSA compliance solution and meets all DSCSA requirements, including:
- Automatic receipt and generation of all components of the Transaction Report.
- Search, verify and communicate product verification and suspect product information.
- Powerful search and query functionality to quickly find information.
- Support of lot-level, unit and aggregated transaction information.
Gain confidence and reduce risk
rCM takes care of all your DSCSA compliance needs and does the work for you, minimizing compliance hassles and concerns while getting rid of other time-consuming tasks prone to error.
Flexibility to address your unique needs
rCM is flexible enough to tailor around your own unique business processes, so you don’t have to recreate them to fit your software.
- Unique data verification technology allows “plug-n-play” integration with existing ERP and other business systems to ensure the highest data accuracy and information flows without hiccups.
- Eliminate the redundancy of getting product information into each of the systems.
- Integrate seamlessly without the need to own or manage any on-premise integration middleware or hardware.
- Save time, hassle and worry – other solutions may offer “out-of-the-box” packages, but they are often inflexible and not able to easily accommodate specific business needs without costly work-arounds.
Data exchange simplified
Share compliance and traceability data with trading partners on the rfXchange™, rfXcel’s verified exchange network used by tens of thousands of trading partners and clinics daily.
- rfXchange™ is a trading platform providing ‘plug-n-play’ integration of all trading partners through a single connection.
- rfXchange™ allows shared visibility and collaboration with your supply chain, interpreting and translating data from multiple formats in real time.
- Facilitate connections to many trading partners via one single connection to rfXchange™.
- There’s no programming or coding required – for you or your trading partners on the network.
Make a secure, direct connection to your trading partners through standard web portals, which interpret and translate data from multiple formats, giving interoperability and visibility to trading partners.
- Easily share data securely with trading partners up and down the supply chain.
- From a single portal, share information so your trading partners can access Transaction Reports and other data, as well as verify product information.
- rCM utilizes an event repository, providing storage and management for unique transactions, events, serial numbers, and hierarchies in large volumes.
- The unique event verification technology embedded within the rCM application ensures data passed to trading partners is validated, verified and accurate, ensuring trading partners have data they can trust.
Flexible and automated reporting ensures you’re compliant
Flexible and automated reports give you the information needed to comply with all DSCSA requirements and free you from manual reporting processes and maintenance.
- Effortlessly create, save, retrieve and exchange Transaction Reports for all your trading partners.
- Easily provide TI, TH, and TS reports on all products to trading partners up and down the supply chain, including those on the rfXchange™ trading network and/or those who aren’t rfXcel customers.
- If you elect to send your Transaction Report via the EDI or AS2 communication protocol, you’ll receive acknowledgement the report was sent and received by your trading partner – giving you confidence the report was received.
- The application also goes beyond DSCSA requirements and provides both lot level (a DSCSA requirement) as well as unit and aggregated serialization information.
Each Transaction Report is available in real-time, is fully configurable for each of your customers, and DSCSA compliant, containing the components below in a single document (per DSCSA requirements):
- Transaction Information (TI): Transaction Information in the report includes proprietary drug name, strength, dosage form, NDC, container size, number of containers, lot number, date of the transaction, date of the shipment, the business name and address of person and company of ownership transfer.
- Transaction History (TH): Highlights the complete chain of custody, beginning with the manufacturer and tracing the product all the way down the supply chain. To ensure data accuracy, all historic information is derived from shipment files in the rCM database.
- Transaction Statement (TS): Built-in report flexibility can be configured to use a statement directly from the manufacturer and also includes a digital signature feature to help save time and hassle.
You’re in total control
Validate your system and upgrade when you want, without the complexity, downtime and disruption to your business.
- rCM is built on private cloud technology, which allows your own unique instance and implementation to be fully validated.
- Unlike multi-tenant solutions running on public cloud technology, rfXcel’s private cloud technology is tailored to meet your unique specifications and requirements, and enables you to be on your own version of the rfXcel solution. There’s no application sharing or forced upgrades that can ultimately negate your validation, giving you more control, reliability and security.
Don’t want or need to be in the private cloud? The rfXcel applications can also be deployed as an on-premise solution should you prefer to manage the IT systems.
Get peace of mind with reliable data
Being DSCSA compliant goes well beyond simply passing Transaction Reports – it’s also about ensuring the integrity of the data being passed is accurate, tested and validated.
- rfXcel’s unique event verification technology helps safeguard against incorrect data by validating and matching information to ensure the data integrity of the Transaction Report – catching errors before they become an issue and giving you and your trading partners peace of mind the information is reliable.
Automated alerts catch errors and exceptions before they become problems
Create custom exception handling triggers, rules, alerts and notifications to ensure you’re on top of all compliance matters and your business doesn’t come to a standstill if “exceptions” are found.
- Determine exception criteria and set the necessary triggers and alerts
- Determine and create unique rules and workflows that must be followed once an exception is triggered.
- Send alerts and notifications to recipients inside and outside your company to ensure everybody is on the same page and appropriate safeguards are in place.
Get insight with automated audit trails
An extensive set of built-in audit trails help you easily find and discover user activities, events and transactions to give you actionable insight.
- Drill into details to better understand the history behind each transaction and event information.
- Audit trails are automatically created when a “request for information” is acted upon, creating a record and report to provide proof the request was acted upon.
Save time with powerful search capabilities
Proprietary data architecture leads to powerful search and data filtering functionality to help quickly find exactly what you need, when you need it.
- All data is stored in a central database and searchable format so it’s effortless and fast to query and retrieve detailed information.
- Customize search queries and report generation.
Gain trust through verification
Product verification leads to improved information and visibility along the supply chain, and helps build trust among your trading partners.
- Product verification gives you and your trading partners key insight into chain of custody and ownership, product authentication and product recalls.
- Verification is a DSCSA requirement, and the rCM application lets your trading partners effortlessly verify serial or lot numbers through customer portals or the rfXchange™.
To save time and hassle, rCM also supports mobile functionality.
Anytime access improves patient safety
As an optional feature, rCM supports a mobile application to give users “instant insight” and help save time, hassle and prevent costly data-entry errors.
- The application works on Android or iOS operating systems, allowing users to instantly verify and authenticate product information and help improve patient safety by scanning linear, 2D and 3D bar codes or reading RFID tags.
- Users can view transaction history and chain of custody information for every bar code scanned or RFID tag read.
Eliminate headaches today and plan for your future success
rfXcel meets your needs today, and also ensures your future success.
- rCM minimizes compliance hassles and concerns and gets rid of other time-consuming tasks prone to error – no more paper tracking and no more headaches.
- We keep your data set for at least six years to help ensure you comply with all DSCSA requirements (for current customers).
- When used with our Serialization application, position yourself ahead of the competition and comply with 2017 DSCSA serialization requirements – today.