Five Questions to Help You Pick a DSCSA Solution
With the July 1 DSCSA dispenser deadline just around the corner, now is the time to choose your compliance solution. The regulations are complicated and have the potential to take your attention away from where it really belongs: on running your business. Choosing the right system can mean the difference between headache-free compliance and never-ending hassle. As you evaluate solution providers, here are five questions to ask.
#1: What’s the difference between compliance software and a solutions partner?
There are multiple systems that promise DSCSA compliance. But a true solutions partner will deliver regulatory expertise, not just a piece of software. The requirements will evolve over time and with FDA discretion. Does your partner monitor this and automatically update their system so you’re not scrambling with every change? Also, certain rules apply to dispensers versus other supply chain members. Select a partner who bakes industry and dispenser expertise into their solution.
#2: Will there be new communication demands, and how will I meet them?
Your ability to comply with the law depends on seamlessly exchanging regulated documents with upstream suppliers. More than ever, you need to build strong business relationships and the channels to maintain them. How will you connect to partners to pass data back and forth? Is there a platform that brings the larger supply chain community together to exchange data, facilitate communication, and forge new connections?
#3: How can I simplify data management?
Your different supply partners will invariably send you different formats of ASNs, not to mention paper. Which system can process all this disparate data, plus digitize paper? If your solution can’t transform paper into electronic T3s, then you have the burden of storing each physical record for six years. Also, discrepancies – an overage, a short shipment -- happen. Some electronic systems can help you identify exceptions and modify the relevant compliance documents as required. DSCSA data management will be challenging; make sure your solution is flexible enough to handle all the permutations.
#4: Who delivers peace of mind?
As a dispenser with direct patient contact, you have a vital role in the supply chain. The right partner will keep you from having to choose between managing requirements or answering important patient questions. The right partner will take the risk out of compliance, too. Suspect product investigations are serious business, with a 2 business day turnaround time. What system puts all your data at your fingertips for easy recall, so you’re not scrambling to find a single transaction history in a stockpile of paper, with
#5: Who does the rest of the industry trust?
Since their deadline preceded yours, manufacturers, distributors, and other supply chain members have already gone through this selection process. Take a look at which providers have worked with the most customers, gathered the deepest expertise, and processed the most transactions. Choose a solutions provider who has blazed the trail and figured out the right formula for achieving compliance.
Compliance requirements are here to stay. Ask the right questions and evaluate your options, because you will be relying on your solution to help you manage DSCSA demands in an efficient, cost-effective way for many years to come.