Dietary Supplement Industry Supply Chain: You Need to Implement Transparency and Regulatory Compliance Software Now. What Are You Waiting For?
Published March 28, 2018
Managing compliance for raw materials, suppliers, and label claims can be the bottleneck slowing the time-to-market for new products. We knew qualifying suppliers and collecting compliance information was inefficient; but we had no idea how widespread the problem was until we spent two years in conversation with hundreds of people working in the dietary supplement industry. We spoke with CEOs, CFOs, COOs, CMOs, and CIOs; plus those responsible for the day-to-day QA, QC, Regulatory, R&D, and Procurement.
They all told us the same thing: they’re overwhelmed. And, if anyone walks out the door, a lot of institutional knowledge leaves with them.
We learned a mid-sized dietary supplement manufacturer manages thousands of raw materials from hundreds of suppliers; tens of thousands of documents; and up to a million data points. Most manufacturers rely on emails, phone calls, spreadsheets, and printed files to manage this complexity. Individual departments often have their own systems with siloed data. One manufacturer we spoke with told us their data was stored in seven different systems!
Former Alacer Corp. (Emergen-C) CFO, Larry Batina, told us, “Staying compliant with regulatory and label claims issues requires significant labor to maintain multiple in-house tools (discrete spreadsheets, emails, and paper), review relevant governmental websites, and rely on vendor-supplied information. Maintaining compliance is very time-consuming, fraught with potential errors and omissions; and requires significant senior management time.”
Late last year, our company Healthnotes® took an important step toward releasing the dietary supplement industry’s first transparency and compliance software. It’s called Vitature®, and it focuses on doing three things very well:
- Supplier Compliance Management—helps manufacturers find and qualify suppliers and manage and collect supplier compliance information.
- Material Specification Management—helps manufacturers research, create, and manage raw material specifications and associated regulatory and science substantiation, and makes this information sharable with suppliers, customers, and regulators.
- Bulk Formulation Compliance—lets manufacturers build bulk formulas by combining raw material specifications, facilitating the management of regulatory and label claim requirements.
Larry Batina agreed having a centralized database with supplier, science, and label claim information, would streamline processes at dietary supplement companies, improve risk management, and advance product innovation. In other words, the way many companies are currently doing business is risky and costly—especially with demands for transparency.
Vitature has a strong ROI, more than paying for itself through efficiency gains, quicker time-to-market, and audit risk reduction. As with any software implementation, there is some upfront effort on your part to get Vitature up and running, but that should be no excuse to wait. As Zig Ziglar put it, “You don’t pay the price for success, you pay the price for failure. You enjoy the benefits of success.”
Here are some real benefits you get once you implement Vitature:
- Reduced resources required for administrative compliance data management.
- Fewer tools needed to manage compliance data and documentation.
- Cloud-based software without the need for updates, maintenance, or hardware management.
- Single repository for collaborating and managing compliance with suppliers and internal teams.
- Less email and phone time spent requesting data and documentation from suppliers.
- Centralized and digitized compliance data for easier searches, queries, and reports.
- Increased insight into supplier and raw material compliance risk.
- Decreased audit risk with regulators and customers.
- Part 11 compliance with digital audit trails and electronic signature requirements.
- Quicker response to compliance-related customer requirements.
- Faster time-to-market for new products with automated compliance processes.
- Scalable software that grows with your company.
If you are involved in any aspect of manufacturing dietary supplements, please check us out at www.healthnotes.com. Discover how we can help you save time and money—and get a better night’s sleep. Most importantly: do it now. What are you waiting for?