Regulatory Compliance
Solution

Regulatory Compliance

Protocol driven approach to complying with specific regulatory standards on an industry level.

Problem

Regulations are driving industries to overhaul their legacy system

The global supply chain compliance landscape is more dynamic today than during any other time in history. Increased stakeholder expectations, heavy fines resulting from non-compliance, delayed market access due to complex global trade rules, and a multitude of overlapping raw materials and product integrity requirements are common challenges organizations navigate.

  • Varying standards and regulations
  • National, state/provincial, local regulatory requirements
  • Industry Standards (e.g. ISO, NIST)
  • Bilateral or multilateral trade agreements
  • Internal Corporate Policies
  • Contractual Agreements
  • Customer and NGO expectations
  • Competing standards
  • React and remediate approach as opposed to preventive or proactive approaches
Regulations are driving industries to overhaul their legacy system
Solution

Our Solution

It’s time to see compliance as an opportunity, not a burden.

  • Codify industry standards into computer code via protocols (e.g. ISO or NIST standards can be converted into multi-company protocols)
  • Collaborative ROI is accomplished when dozens of players in an industry plug into a protocol solution to achieve compliance
  • When we identify and solve business problems that cut across multiple companies with a protocol, then we can deliver ‘collaborative ROI’ to the enterprise
  • Don’t just see compliance as a burden but an opportunity to get connected and find other business transformation benefits

Areas of Application

Industries that can benefit

  • Pharma
  • Chemicals
  • AgriChem
  • Agriculture
  • Nutraceuticals
  • Vitamins and Supplements
  • Livestock
  • Personal Care and Cosmetics
  • Food
  • Automotive
  • Aerospace
  • Logistics

Some of the industry regulations where this solution can help

Guns
Gun Control Act of 1968 and other gun laws

Regulate interstate commerce of guns and other restrictions on buying and selling guns

Food
Food Safety Modernization Act

Ensure that ingredients are sourced from approved suppliers and handle food recalls

Pharmaceuticals
Drug Supply Chain Security Act

Establish system for detecting and removing potentially fake or contaminated drugs

Tobacco
EU Tobacco Track and Trace law

Reduce Illicit tobacco trade

Cosmetics
Personal Care Products Safety Act

Trading partners must register their facilities and maintain a record of the ingredients in each product

Seafood
U.S. Seafood Import Monitoring Program

Importer of record must capture the information about seafood origin and ensure compliance

Commodities
U.S. Conflict Minerals Law

Independent third party audits of traceability and submission of these audits to the SEC

Success Story

DSCSA compliance in the Pharmaceutical industry

Pharmaceutical companies in Europe and the US are required to serialize, track, and verify their drugs from production through to dispensing, to ensure safety and legitimacy. In the US, they must do so with an interoperable digital method by 2023.

Chronicled launched the MediLedger Project in 2017 as an ecosystem for the pharmaceutical industry. The Saleable Returns / Verification and Confidential Change of Ownership Solution Protocols leverage GS1 standards, and register ‘proofs’ ofs supply chain events to an industry ledger blockchain backend. The solution protocols emerged after a year of requirements gathering and R&D within the pharmaceutical industry working group members, and is solving problems such as data privacy, exception handling, and aggregation. This hub and spoke data exchange minimizes integration costs and integrates easily with existing systems and scanning and packaging infrastructure.

By logging key supply chain events in an anonymous way, privacy is achieved while also full-item history, and quality control, and mico-second verifications are assured. The result is a safer, more compliant flow of critical, often lifesaving, pharmaceutical products.

Learn more
Regulations are driving industries to overhaul their legacy system
Blog Posts

Compliance Can Drive Innovation. Here’s Why And When It Works

Blog Posts

Why Blockchain Is Behind The Change Coming To Regulated Industries

Press Articles

MediLedger, Chronicled and blockchain