Meeting requirements in growing global markets makes regulatory compliance an increasingly complex issue for chemical manufacturing companies. Before a product can be released into the markets, companies must register their products and active ingredients with each regulatory agency of each country that the product will be sold in.
This process has traditionally been a lengthy one, requiring years before a product can hit the market. Even the smallest errors in registration, production or manufacturing can result in potentially disastrous consequences, causing product distribution delays and millions in lost revenue.
Whether it’s complying with the Toxic Substances Control Act (TSCA) or following good laboratory practices (GLP), managing regulatory requirements and consistently producing a high quality product becomes very complicated.
Top Considerations For Chemical Companies
- Visibility - Many companies continue to use paper-based or outdated on-premise document management solutions. These systems can create blind spots and lead to a lack of transparency. Chemical companies require a system in which they can clearly manage and track global regulatory submission activities, ensuring compliance.
- Control - Chemical companies must be able to easily control access, visibility, and permissions to make sure that only the right people take the right actions at the right time, without compromising data integrity or consistency. Having the ability to document changes ensures performance, reliability, and safety and guarantees that all processes meet compliance standards.
- Efficiency - With thousands of regulations to comply by in dozens of countries around the world, keeping track of documents and submissions can become difficult. Having an effective document management system ensures efficiency and helps to reduce errors and costs. Moreover, achieving efficiency has a direct impact on the time it takes to release new products to markets. An efficient system enables reduction in time to market which translates to significant cost savings and increased revenue.
Ensuring Regulatory Compliance with Veeva
These were the challenges facing one of our current Veeva chemicals, oil and gas customers. The company was using an outdated on-premise Enterprise Content Management solution that had become difficult to maintain and couldn’t keep up with the company’s changing business needs.
The company needed a document management solution that would enable it to meet it’s annual regulatory submissions of 1,000. The new system would need to be configured to follow GLP and various regulatory compliance needs across multiple regulatory jurisdictions.
By leveraging Veeva QualityOne Doc Control solution, the company was able to accelerate the creation, review, and approval of regulatory submissions. It also improved the tracking and reporting of submission activities, as well as provided a simple document management platform for study reports, quality processes and SOP document management.
Establishing a robust, cloud-based document management solution provided this company with the tools to meet the complex global regulatory and compliance requirements, as well as make its quality and submissions processes efficient.
Quality and compliance is a critical issue faced by many companies in the chemical industry. Veeva QualityOne is committed to improving the way organizations manage their quality processes and content.
To learn more, join us at the 2018 Veeva Quality Summit. This event is designed for manufacturing quality professionals and their IT partners in the chemicals industry as well as from other regulated manufacturing industries such as CPG, Cosmetics and F&B.