Does your life science organization need to adopt a compliance software tool?
Determining the need for compliance software isn’t necessarily straightforward; there are a lot of factors that come into play. However, there are many common signs of trouble—some of which may not be readily apparent—that indicate these tools might be beneficial to your organization. Being able to identify these signs assists your team in understanding what their current needs are and how compliance software tools can help.
1. Generating deliverables for regulatory submission is a hassle
A fair amount of time and effort are needed to take your life science product’s design data and prepare it for regulatory submission. The right processes can streamline these activities. However, continued issues in generating compliance-ready deliverables, even with robust regulatory procedures in place, could mean additional tools are needed.
2. Your compliance activities are reactive instead of proactive
Reactive approaches to compliance can sometimes be handy in the short term, but in the long run can be detrimental to your organization. Anything from internal remediation to external, regulatory audits can cause your business serious headaches that impact your products, profit margins, and reputation in the marketplace.
3. There are transparency and oversight issues
If you can’t easily tell who on your development team has been generating, touching, and altering your product design data, that’s a critical issue. Lack of data control can mean data loss or other serious problems that result in intensive remediation and other negative effects.
4. You’re losing time to market due to compliance activities
The longer it takes to prepare your product for regulatory submission, the longer it takes to get to market. Not only does this apply to the time actually required to generate your submission, but also to quality issues that slow down the review process and potentially end in rejection. This lost time can eat away at your investments of various resources into a project. Plus, it can influence your organization’s ability to make progress on other projects.
5. Your product development data is isolated in multiple sites
Life science product development, by its very nature, results in the generation of vast quantities of data. It’s difficult enough to manage all this information at one work site; when your development activities are split across multiple locations, the challenge increases exponentially. Being able to maintain the quality and accuracy of that data, whether it sits at one site or migrates between multiple facilities, can become far more prone to error, especially as additional data is generated.
6. Your teams struggle with integrating risk management
Risk management is a difficult and intricate part of the compliance process for life science products, but it’s perhaps the most essential. Not being able to show your organization took the steps to ensure the product is safe and effective will likely cause your submission to be rejected by regulators. Though you may have solid procedures for risk management in place, integrating that into your design control activities and eventually your submission deliverables can still be overwhelming.
