FDA Title 21 CFR Part 11
The stringent regulations imposed on life sciences companies are in place for a good reason—to reduce the health, safety, and security risks faced by consumers of pharmaceutical, medical device, and biotechnology products. But for the companies that must comply, the regulations themselves also pose risks. Firms that fail to meet regulatory requirements face fines, delays in getting products to market, or having the sale of a product blocked. The harm to a company’s bottom line can be dramatic.
This webinar will explore different ways you can ensure that your maintenance records are compliant with FDA regulations. Infor EAM for Life Sciences includes built-in functions to make this part of your workflow. It also has the ability to produce the information that FDA auditors will be looking for when they inspect the maintenance records of your assets. This will ensure a smooth and speedy audit, so that your staff can continue working on day-to-day operations, worry-free.