Many organizations tend to stick with what’s worked for them in the past for regulatory compliance due to its complexities and the need to assure that new products are safe and effective. This is especially true when it comes to compliance activities such as design controls. While this attitude is understandable, it does present some problems. It can limit an organization’s ability to remain competitive in the market, and it can also impede long-term business growth.
One method to solve those problems is the adoption of compliance software tools. These tools are designed to simplify the compliance process while maximizing product quality from concept to commercialization. But why change your approach when it comes to your organization’s compliance activities?
1. Centralizing project databases
In today’s changing life science ecosystem, globalization has allowed for dispersed teams to work on the same projects remotely. However, when this data remains isolated at these sites, a number of quality issues could arise. With an online compliance platform, however, you can unify that data and maintain it within a single location, thereby reducing the likelihood of human error or data loss.
2. Promoting long-term growth
Life science industries are increasingly turning to digitalization and new approaches for product development. To manage these shifts adequately and to maintain viability in the long term, organizations need to use tools that promote these goals. With compliance software tools, your teams can more easily shift away from paper-based development systems and go toward an enhanced methodology for product development.
3. Empowering innovation
When your teams don’t have to worry about the intricacies of regulatory compliance, they can focus on making more advanced products. Because the software tools simplify the process of generating compliance-ready deliverables, less effort is needed to transition from innovation to activities such as design controls. This allows more opportunities for inventive ideas and solutions to emerge, transforming your products and services.
4. Streamlining compliance activities
Regulatory compliance isn’t always straightforward; there are many angles that have to be worked in order to get your life science product from concept to submission. This complexity can become confusing and overwhelming for development teams. When a compliance software tool is leveraged, however, this complexity is mitigated. The process of bringing your product into regulatory compliance is simplified and streamlined, saving time and resource costs.
5. Greater traceability
The right compliance software tool comes with robust traceability built into it, which is critical in modern life science product development. Being able to track product requirements, tests, risk controls, and all other pieces of data related to your product up and down your project levels is enhanced within a compliance platform.
6. Improving accountability
Along with traceability, a powerful compliance platform has features for auditing and data control, allowing you to see who has touched what information and when. In paper-based systems, maintaining accountability is infinitely more difficult—especially if remote sites are passing data back and forth without rigorous supervision.
7. Decreasing time spent on documentation
One of the greatest investments of time and resources when it comes to regulatory compliance is documentation. Making sure your data and deliverables accurately address regulators’ concerns and meet the applicable requirements for clearance to market takes a lot of time and energy. Generating a single design controls document alone could be dozens of hours of work at best. When you have a compliance platform that helps your development teams generate submission-ready deliverables from the start, however, this investment is greatly reduced and better controlled without sacrificing documentation quality.
