Life Sciences

What Are CAPAs And Why Are They Important?

argus-safety-CAPAs

 

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.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

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.

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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.

About the Author

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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