The healthcare industry, whether it involves pharmaceuticals, biotech treatment protocols, or medical devices, is highly regulated—as it should be. Because the FDA has been established to ensure public safety as the latest healthcare innovations are brought to market, audits will happen. They must.
But the audit process doesn’t have to be scary. LuminLogic, a 21 CFR Part 11 compliant SaaS solution that supports document, regulatory, quality, and risk management systems for medical device, pharmaceutical and biotech companies during the commercialization process, can take the stress out of audits. Our audit management software solution enables you to attain and maintain compliance by automating, streamlining, and managing the auditing process.
Not only does the FDA conduct audits to ensure your business is operating in a way that supports the approved and safe use of your products, your company sponsors and partners will perform audits to confirm that you’re supporting their regulatory obligations. So, during and after product commercialization, accurate data tracking—and your ability to show it—is imperative.
A robust audit management software solution sets a secure foundation for streamlining any audit process. When you can collect and track data with on-demand reports that identify document creation and modification specifics, you’ll be able to provide custom documented information trails to meet precise auditor requests.
“Audit” doesn’t have to be a bad thing. If you’d like to learn more about the LuminLogic audit management software solution, reach out to us today.