life sciences, compliance risk, trade compliance, automation

For the heavily regulated life sciences industry, export compliance is critical. There are exacting regulations when you ship hazardous materials, scheduled medicines or biological matter. Non-compliance can result in delayed shipments, canceled orders, fines and damaged reputations. That’s not ideal for any company, but when the health and well-being of people is dependent on your products, avoiding compliance delays is vital.

Despite this, a Deloitte report on compliance found that many life sciences companies do not have an enterprise-wide view of risk. This is partly due to globalization and the need to work within different regulatory environments. The more a life sciences company moves into new markets, the more risk it faces. After all, the more countries you do business in, the more regulations you need to adhere to.

For a long time, companies across many industries have treated trade compliance as a box to be ticked. Because of this, many companies do — and spend — the minimum to avoid compliance missteps. As Deloitte notes, this is no longer enough. Get it right and compliance can be a competitive advantage.

Three Benefits of Automating Trade Compliance

Compliance, like housework, is never done. Regulations are subject to change. Products that can move freely today may face stricter export controls tomorrow. Denied parties and government lists of sanctioned individuals are not static. Changes can occur several times a week. Then there’s the paperwork. Compliance procedures and documentation can change without warning. All these create the risk of shipping delays. Automation allows companies to mitigate risk while keeping abreast of current regulations. Here are three benefits to compliance automation.

Increased Internal Efficiencies

Manual compliance processes are time- and labor-intensive. In many organizations, compliance decisions rely on the knowledge of key personnel. If these staff members leave or are unavailable, decisions are not made, or worse, violations occur.

Automated compliance tools take the guesswork out of compliance. They use historical data, real-time regulation information, previously stored customer and partner profiles, as well as business rules to create a compliance workflow.

Track Critical Processes

A further benefit to automating trade compliance is that it improves visibility and reporting across your global trade activities. Life sciences companies are always subject to the risk of audits and must be able to prove regulatory compliance. Some companies may need special licenses or permits to market their products in certain countries. Either way you must be able to show proof of these applications, licenses and permits when and if requested by authorities. If you automate trade compliance, every process, workflow and report is tracked, documented, organized and stored for future reference. This audit trail allows life sciences companies to show ongoing compliance with international regulations.

Ensuring Compliance

When life sciences companies use automated trade compliance, they can run multiple compliance checks quickly and easily. Most companies will perform a check at the beginning of a customer relationship, but with an automated solution, you can run a compliance check against every order to ensure that the sale can proceed. Denied party lists are subject to thousands of changes every year. Manually tracking this is virtually impossible. Compliance automation removes the possibility of human error and gives you a consistent risk-mitigated approach to global trade.

Evaluating Automated Compliance Solutions

When life sciences companies evaluate trade compliance solutions, there are four critical questions to ask:

  1. Does the solution offer real-time updates to trade content from regulatory agencies around the globe?
  2. Is flexible compliance screening offered by product, partner, organization or country?
  3. Can the solution identify and manage license requirements by country, item, date, quantity or value?
  4. Is it possible to integrate compliance checks with export documentation production and outbound shipping processes?

How QAD TMS Can Help

QAD Transportation Management System (TMS) integrates trade compliance and transportation. At the beginning of the export process, QAD TMS verifies your trading partners and validates the country of destination to ensure the sale can proceed. Flagged shipments are automatically put on hold and key personnel are alerted.

QAD TMS also automates export processes, including documentation production and customs reporting. All the documents required to complete a shipment are prepared correctly. This includes documentation for specialist life sciences products as well as hazardous or infectious goods.

It is possible to use different systems for trade compliance and shipping. However, this time- and labor-intensive process increases the risk of human error and creates data silos. By integrating compliance and shipping, QAD TMS can help streamline processes and enable our customers to build the effective enterprise.