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Attaining and preserving market access for products is both a challenging and reiterative process. With the ever-growing list of sophisticated regulations, fulfilling product compliance has become an increasingly complex endeavor. Part of the complexity is due to regulations requiring more information and data. There is a growing dependency on information collected from and shared with customers, suppliers, regulatory agencies, and service providers. To address this, everyone involved must work together and be proactive in sharing product compliance data.

The fact is, as the safe and effective management of chemicals continues to evolve, so does the demand for chemical and product information. In this blog, we discuss the challenges product stewards face in collecting and sharing compliance information and point to ways to meet those challenges.

Types of Compliance Data: Internal vs External

Product compliance data can generally be sourced from two spaces:

1. Internal - within your company. For example, you get mixture formulations from product development, and you get information about intended markets from marketing or forecasted sales orders.
2. External – from outside your company. For example, this includes getting data from suppliers providing raw materials

Sharing data can take many forms: from simple, such as letters or phone calls, emails with files and documents, to complex, using elaborate systems, databases, and platforms.

What we have observed is: there is no single answer to engage the different actors and address the different needs when collecting and distributing product compliance information. Product stewards have to employ a breadth of strategies to make it work.

Challenges in Exchanging Compliance Data

Whether obtaining product data from within your organization or from external sources, it is not always a walk in the park. Drawing from our long experience working with both mid-sized to some of the largest chemical companies, here are some of our observations of the challenges product stewards face:

• Identifying data gaps: this can range from physical-chemical properties to contacting the right suppliers for data and documents, certificates, and safety data sheets
• Resource intensive: collaborating with external parties takes time. And time = resources. People can be slow to respond to email, voicemail, or simply be away on a long vacation
• Aggregating and interpreting data: product stewards often receive data in various formats that are not necessarily consumable and require modification or translation
• Inconsistent audit trail: not all sources of data will live up to an audit
• Securing market access: when entering new markets, it is often a challenge to efficiently manage notifications and registrations required by regulatory agencies

How do we address these challenges?

We need to:

• Make sure a large number of processes collecting or sharing information run smoothly
• Handle large amounts of data, information, and documents
• Engage a multitude of internal and external actors

Every company uses software to run nearly every aspect of the business; why not use it for stewardship activities?

Overcoming the challenges of collecting data internally is best done by establishing processes and standard procedures. Most companies have a well-established ERP system, such as SAP. Within such a system, it is possible to pull and push data from other neighboring modules (if required) and check for data consistency.

The other challenge is obtaining and aggregating data from external sources. As mentioned earlier, data obtained tend to be quite unstructured and not always auditable. Obviously, the best solution is one that reduces time and requires minimal resources, i.e., the maximum speed with minimum effort. Thus, a software solution is going to be the most sustainable option in the long run and able to deliver the best quality.

What to Consider in Collaboration Platforms

In terms of software, there are countless options, serving different purposes. How do you pick the one that best supports data exchange from outside your company? Here are two questions to consider in your overall product compliance strategy.

Where are you in the supply chain and how diverse is your external network?

Depending on where you are on the supply chain, your suppliers may be the smallest family-owned business, giant multi-national corporations, or (most likely) a mix of both. How are you communicating with them? Are you calling them regularly to chase data? Or are you one of the many people included in cc in a never-ending email thread?

You might also want to consider other factors such as regional and cultural differences, languages, varying expertise in product compliance, and readiness to adopt IT solutions.

Our recommendation:

Look for solutions that truly enable and support all actors, i.e., internal resources and external providers of all sizes, to collaborate and have access to all necessary information, data, and documents. A best-in-class solution should have lightweight options for your smallest suppliers while also supporting more advanced types of data formats.

Where are the gaps in your overall product compliance process? How are you keeping up with regulatory updates and changes?

The various platforms in the market often have a specific focus. Are you looking for supplier network management? Or are you looking for a solution that provides the latest regulatory updates and exchange information with authorities? Or are you looking to outsource fulfillment of product compliance to a service provider?

Our recommendation:

Find a solution that can connect to various aspects of product compliance and support your product compliance strategy. This means that probably need to combine more than one solution. Just ascertain that the solutions you choose are flexible and inclusive.

After you’ve identified what you need, the question of integration is very crucial. How do the product stewardship solutions integrate to support your overall system landscape? The best advice we can give is that you must always maintain a single source of truth. For example, if you’re using SAP S/4HANA for product compliance, then the solutions should have deep integration with SAP. This gives you the advantage of acting efficiently and/or adapt your company’s changing and specific needs.

What other challenges have you faced? Do you have additional recommendations you’d like to share? Comment below or send me a message on LinkedIn. I'd love to hear your thoughts on this topic!

About opesus

Opesus provides SAP-based software solutions and consulting that allows companies to run sustainable businesses. Our extensive product development and technical expertise allow us to offer effective and efficient technical solutions that complement the offering of SAP. We collaborate closely with SAP, industry, and authorities, making us the first and best choice whenever customers of SAP have requirements not covered by SAP’s standard solutions for Sustainability.

Our latest solution, Product Compliance Collaboration (PCC), understands the complexity and many moving parts in product compliance. PCC is designed to orchestrate the many elements of your overall product compliance strategy.