ISO 13485, CAPAs, QA requirements, 21 CFR Part 11 compliance? The list goes on for medical device manufacturers and organizations in the life sciences industry. With so many regulations to stay up to date on, it can become easy for your team to make mistakes on how they handle their records, whether physical or electronic. Not having the right training program in place can lead to more mistakes being made and can ultimately lead to frustration and higher employee turnover within your organization.
Personally, I think there’s two ways of looking at this. You can use these regulations and processes as a differentiating factor and a competitive advantage or, you can yield to mediocrity and end up with the FDA micromanaging your organization. Having a robust training platform will be critical if you’re trying to ensure that your employees are performing their tasks efficiently while remaining compliant with federal regulations.