Product Stewardship and Regulatory Affairs (PSRA) managers in the specialty chemicals industry don't have it easy these days: an ever-increasing number of new regulations creates a flood of requests for information. In addition to those inquiries, they must ensure compliance with all regulations at all times.
Regulatory affairs managers in the specialty chemicals industry have to deal with an increasingly complex set of regulations. One example would be the demarcation between REACH and the Biocidal Products Regulation (BPR) and the many questions that this raises requiring consideration from numerous stakeholders.
At the same time, changes in the risk assessment of certain substances or substance groups are the order of the day and can jeopardize the future of profitable products overnight. Does our ingredient we are supplying to customers for their planting pot preservative paint trigger allergies? How far will the use of titanium dioxide be restricted in the future?
5 Ways to Improve Product Stewardship and Regulatory Affairs Compliance
Regulatory experts have to filter relevant information for affected product groups from a huge pool of documents and data in the shortest possible time - in a reliable, current, and accurate way. How can this work on a global scale across all department and country boundaries?
Here are 5 ways we at Veeva have seen chemicals industry leaders improve compliance, speed, and accuracy while mitigating risk.
1. Recognize product stewardship and regulatory affairs as business enablers
The hurdles to bringing compliant products to market for the customers of specialty chemicals manufacturers have never been higher. That is why product stewards should accompany the entire life cycle of these products. But unfortunately, most companies are still missing the most effective tools to get the job done. Business leaders regard product stewardship and regulatory affairs (PSRA) as an auxiliary function only.
Specialty chemicals manufacturers should consider changing this and increase the value contribution of PSRA teams to the company. The first step is a detailed analysis to answer the following question: Where in your company could the PSRA teams positively influence strategic and solution-oriented projects?
Searching for future-proof chemical alternatives, taking sustainability into account, should be part of daily business for PSRA teams. Then consider what hurdles stand in the way and work on an action plan to clear them out of the way.
2. Stop using spreadsheets and shared documents to manage complex business processes
According to the 2021 Regulatory Management Trends Report, 94% of regulatory affairs teams are still using standard enterprise tools like the Microsoft Office Suite and Google Docs. Unfortunately, such information management is extremely error-prone and therefore represents a huge source of risk for companies. It offers no transparency, automation, and only very limited possibilities for review.
Additionally, this technology mix does not meet their current and projected business needs as 39% of surveyed professionals recognized the increased need for digital transformation related to regulatory affairs.
Dedicated digital solutions for regulatory information management store data and documents securely in a central location and make them accessible to all stakeholders. Automated workflows ensure that all relevant employees are notified as soon as there is something new. The current trend toward digitization is playing into the hands of regulatory affairs experts who want to rely on modern tools. Presenting a well-thought-through business case to the C-level on how a cross-departmental system can facilitate regulatory compliance management will find open ears.
3. Actively look for efficiency boosters
Regulatory Affairs departments are often understaffed and overburdened by isolated processes and a lack of data transparency. It is all too easy for regulatory experts to lose focus under the burden of administrative tasks. The only way out of this situation is to take a critical look from the outside: Where can you gain greater efficiency and improve processes? How can future trends be identified?
One possible way to achieve this is through specialized software solutions that reduce the administrative burden of regulatory affairs. They help relieve employees so that they can devote their time to value-adding tasks like risk assessment for a planned product or for a new formula, verification of raw materials and sources used, or coordination at global, regional or local levels.
4. Examine process efficiencies
However, software alone is not enough. Specialty chemicals organizations that previously thought and worked in silos must also review their processes and establish new best practices. Saying goodbye to individual spreadsheets, documents sent by email, and storage on scattered file shares is not easy. In addition, existing data that is transferred to a new system must be sifted and cleaned up.
This requires real teamwork. All stakeholders - regulatory, IT, and other affected areas - must pull together. They need to determine how employees will work more efficiently in the future and use a new system as a single, reliable source of information (single source of truth). A technology partner that understands the big picture can help optimize processes and map out implementation.
5. Take a look beyond the horizon of your industry
It is essential to formulate clear goals and set key performance indicators (KPIs) right from the start to keep the regulatory modernization project on track. Many managers in the specialty chemicals industry measure themselves against benchmarks in their own industry. But what if the industry as a whole is lagging behind technological progress?
Forward-thinkers also look at other highly regulated industries and how they deal with similar challenges. They actively network. More and more regulated companies are standardizing their compliance-related activities with modern cloud-based applications, creating transparency and increasing productivity. There is one main reason for this: these solutions engage all manufacturing sites, supply chain members, external and internal stakeholders, and encourage their collaboration.
How to Get Started
Due to their comprehensive knowledge of current and planned regulations, PSRA departments in specialty chemicals are increasingly assuming a key function within their organizations. PSRA expectations are going to increase and the ability to scale will separate the leaders from the laggards. Sustainability, transparency, supply chain collaboration and product compliance, and customer request management are changing how companies do business. Regulatory needs to ensure it has a seat at the table.
With software-supported measures to reduce the workload and increase the productivity of the employees working in this area, manufacturers are setting the course for mastering current and future challenges such as the circular economy.