DSCSA Compliance, Difficulties, and Solutions
Among a lot of reasons that are presently surfacing around FDA track and trace capability, most primitive ones are misconceptions around the definition of product identification and verification. The other is financial, commercial, and infrastructural gaps between large, small, and mid-size companies.
Verification? Product Identification? Definitions Under DSCSA
There are essential issues in how the modern pharmaceutical industry interprets product identification and verification. It is often misunderstood that verification of product identification means that the manufacturer, repackager, is expected to verify whether they make the product. Or there is an identification on the counterfeit in a particular Pharma supply chain automatically point in time.
As per DSCSA identification and verification definition, the manufacturers and the higher-level partners in a supply chain have been bound to ensure (at any time) that a particular request a product verification helps them verify that the product. It includes an identification number, lot number, and other details that are the same as available on the human-readable label and the one submitted to the USFDA regulators.
Resource & Commercial Gaps Among Companies
The commercial, financial, and business capabilities of a well-established pharmaceutical giant, a mid-scale company, or a freshly approved Pharma company would be different. DSCSA compliance is facing significant hurdles. The large-cap companies are capable of undertaking the serialization process and make the necessary changes in their production facilities. But, they are lacking the right business leadership and the required information for successfully carrying out the compliance process. The mid-scale and small pharmaceutical companies are having significant trouble in building a commercially feasible manufacturing and supply chain model. The focus is on embedding the serialization process via contacted manufacturers or a portion of it that remains in the house.
No Standardization of the Serialization Process
One of the hurdles faced by the DSCSA serialization process is that there is no standardization of the serialization process. New-age startups and well-established companies and their CMOS or CIOs are coming out with consultancy services ‘Serialisation as a Service’ concept consulting the short, less resourceful time to managing to get through these processes. Industry experts and thought leaders have outrightly dishonored the idea of one to one consultancy on a global matter, and it is not advisable.
Benefits of DSCSA Compliance and Why Every US Pharma Business Needs It?
What Is The Real Solution?
DSCSA Compliance can be best managed with strategized, well-structured intervention of technology product that is capable of foolproof security, safety, and data security compromise concerns. It should be bringing all the primary and secondary stakeholders of a farmer supply chain to a single solution. Standardization of the serialization process and decentralization of information is a must. The centralization of vigilance should tope it and policing efforts. They are more critical for a sustainable, successful stride of DSCSA Compliance with the help of DSCSA Software.
What Makes DSCSA Compliance More Feasible?
There have been various entrant Technology Solutions that are getting on and off the Pharmaceutical Landscape. A completely foolproof, robust Blockchain-Based Serialization Solution, DSCSA Software is all you need. Fortunately, the Blockchain is one Technology that is capable of documenting Transactions on a Decentralized database with 99.99% data immutability at all ends. It is the perfect solution allowing a vast number of private or permissioned vendors to register over a Blockchain Platform voluntarily.
It verifies the profile and makes them a part of a wholly secured, highly transparent Pharma Supply Chain Solution. It is a great Solution that Allows Real-time Transactions and foolproof consensus management across all regulators and the leading supply chain partners. It helps in executing supplies across the pharmaceutical consumer base.
Business Benefits of using a DSCSA Compliance Software
No FDA penalties
Keeping all Pharmaceutical Supply Chain operations abiding by the Serialization process drastically reduces the chances of ending up FDA sanctions and suspension of Services.
Blockchain day, The Traceability Solutions, and DSCSA Software bring SCM operations a lot closer to the SCM compliance eliminating all possibilities of stolen, counter feet, and low activity Drugs.
Expanding wide across more Rx rugs for Manufacturing deep down the consumer base is more affordable and feasible with an end to end Serialization Solution.
Business Beyond Boundaries
The power of Blockchain-Based Private and Formation Registries over the Blockchain Platform to successfully impaneled vendors and officially communicate with other partners in the Supply Chain anywhere across the world.
Bulletproof data security
Blockchain Technology is capable of building a decent life Database with imitable Data records in the form of Smart Contracts. All the product-related information and Realtime Transactions are highly secured.
Reduced Compliance Costs
DSCSA Software Solution is capable of drastically reducing the overall compliance cost, which in turn causes higher profitability in the long run.
Eight Times Better Fault Tolerance
Blockchain-Based DSCSA Software enables suppliers and partners and regulators to identify notice, red flag, quarantine that are passed into the Supply Chain just with the help of a click.
The high efficient DSCSA Compliance Software enables companies to focus on cutting costs department wise.
The Highly Secured and process includes resource utilization rates and makes the human resource capital way more efficient than ever before.
Forceful intrusions of Technology in Pharmaceutical Traceability and Serialization can make DSCSA Compliance way more comfortable than it looks from the outside. Highly robust, new-age Blockchain-Based DSCSA Software eliminates the hassles of building and managing a Technology Platform. Now you can Setup Serialization Solutions with leading Blockchain Development Companies that are making efforts towards standardizing the process Drug Serialization on a Global Scale.