In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following U.S. laws and quality standards:
- 21 CFR 820.100 (corrective and preventive actions)
- 21 CFR 211.180 (general requirements)
- 21 CFR 820.90 (nonconforming product)
- 21 CFR 820.198 (complaint files)
- 21 CFR 820.200 (servicing for durable devices)
- 21 CFR 820.250 (statistical techniques)
- ISO 13485
- ISO 9001
According to this FDA attorney, the majority of FDA Form 483 observations and warning letters cite CAPA deficiencies. Due to the prevalence of these findings, it’s essential to leverage a 21 CFR Part 11-compliant system to help track and manage these issues.
Did you know that you can leverage your existing drug safety and pharmacovigilance system? Well, it’s true. To read other posts in our “Argus Safety for CAPAs” blog series, click here.