3E helps Merck navigate complex regulatory landscape with speed and accuracy

Merck is a premier research-intensive biopharmaceutical company pioneering innovative health solutions to advance the prevention and treatment of diseases in people and animals. With an enormous Life Sciences business in North America operating under the name, Millipore Sigma, Merck manages a huge portfolio of approximately 300,000 pharmaceutical and biotechnology products, ranging from solvents, to reagents, traditional laboratory equipment, membranes, filters and more.

Merck's portfolio of products has grown exponentially since 2000. In addition, the global regulatory landscape has evolved significantly over the last decade, increasing demand for accurate, up-to-date safety data sheets, on demand compliance verification, and complex marketability assessments based on regional regulations.

Merck relies on 3E ERC+ to help them streamline and expedite creation and management of SDS across their expanding product portfolio. They also leverage the tool to provide marketability assessments and impromptu product content queries.

“We're producing 300 times more safety data sheets in 2024 than we did in 2000. Yet, the team that handles SDS has only doubled in that same amount of time. The ability to handle the exponential increase in volume is only possible thanks to the rule sets and regulatory content from 3E ERC+.”

– Andreas Ehlers

Challenges

Sold around the world, Merck's products are subject to extensive regulations. Not only is the number of regulations daunting, but the legislative landscape is rapidly evolving and encompasses thousands of regional guidelines. Head of Digital Transformation and Hazard Communication at Merck Life Sciences, Andreas Ehlers, and his team handle everything from product registrations and classifications to packaging compliance, product safety and sustainability. The enormity of this task is not lost on Andreas, who is passionate about leading digital transformation initiatives to drive efficiency, accuracy and speed in compliance, safety and sustainability.

Merck previously relied on digital templates to streamline the capture and storage of product information. However, the complexity and scope of information required for adequate safety, compliance and sustainability reporting rendered legacy solutions insufficient to accomplish the task.

“In 2008, compliance with REACH in the EU was the primary topic of discussion. Today, it's not just about EU regulations, but a complex web of regulations that span the globe, from Europe to the United States, Asia and beyond,” explained Andreas. Increased complexity required increased performance of digital solutions.

Achieving results

Today, Merck has more than 29 million active SDS. The daunting task of creating and managing these sheets is made possible with 3E ERC+ and updated templates that conform to increasingly complex compliance requirements worldwide.

“3E solutions are a cornerstone of our regulatory work. It's impossible to keep up with all of the latest regulatory data, so 3E content, rule sets and templates are allowing us to efficiently update our SDS content every six months,” said Andreas. “This helps ensure that SDS sheets are accurate and updated, reducing risk and ensuring preparedness in case of a safety or chemical exposure incident.”

Once authored, Merck is able to maintain its 29 million active safety data sheets with the help of 3E Protect. 3E Protect provides Merck with chemical inventory and SDS management capabilities, allowing Merck’s facility staff to quickly access any one of their millions of up-to-date SDS at any time.

As new products are prepared for launch, the team can run specific reviews by ingredient or region to understand if products are in compliance. In many cases, the team needs to screen entire portfolios of tens of thousands of products within a short timeframe and without monopolizing limited compliance resources. Thanks to 3E's automation, the team can now confidently respond to inquiries on demand without requiring days of work.

Merck also enjoys the dependable regulatory information and updates made available in 3E Insight for Chemicals. Powered by 3E's team of regional regulatory experts, 3E Insight provides critical information in an efficient, cost-effective way.

3E's seamless integration with SAP S/4HANA Classic streamlines data consolidation required for Corporate Sustainability Reporting Directive (CSRD) reporting, which includes expanded standards for sustainability reporting.

Looking ahead

Merck is currently undertaking the transition from SAP S/4HANA Classic to SAP S/4HANA New, furthering their ability to embed automation essential to viability in the global marketplace.

Looking ahead, sustainability is the next hurdle on the horizon and the challenge is distinct from compliance. As CSRD reporting requirements continue to expand and evolve, the only certainty is that visibility and agility will be required. For this reason, Andreas envisions moving to a world where the speed and accuracy of AI empower regulatory departments like his to gain greater visibility, streamline compliance and documentation, and foresee challenges to enable the advancement of compliance, safety and sustainability in one fail swoop.

“We regularly receive inquiries on product sustainability, system and data readiness related to supply chain risk and reporting. We feel good about our capabilities, but we are on the cusp of operating in a landscape characterized by complex regulations, agile marketplaces and resilient supply chains. Vitality will require even greater insight and agility,”
noted Andreas.

As they look toward the future, 3E is there to equip them with solutions that empower safety, elevate stewardship and enable sustainability.

Choose 3E

For more than 35 years, the world's leading companies have trusted 3E to provide the intelligent compliance solutions they need to ensure safety and sustainability while creating new opportunities for growth. Our unmatched Environmental, Health, Safety and Sustainability (EHS&S) and product-compliance expertise empowers clients to improve chemical and workplace safety, product safety and stewardship, and supply chain transparency. Actionable intelligence informs globally responsible business practices and improves Environmental, Social and Governance (ESG) performance.

We are deeply committed to serving our more than 5,000 customers worldwide, including nine of the world's top ten chemical manufacturers, eight of the top ten retailers and seven of the top ten pharmaceutical companies.