Life Sciences

21 CFR Part 11 Compliance For CAPAs In Argus Safety

capa-system-drug-safety

 

We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series. 

CAPA Rule:

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System must comply with 21 CFR Part 11

How does Argus Safety support this rule?

Oracle’s Argus Safety is compliant with both the electronic record and electronic signature components of 21 CFR Part 11. However, it’s important to note that the system does not support biometric signatures, which are also governed by 21 CFR Part 11.

We hope you’ve enjoyed our series on using Argus Safety for CAPA management. If you have any questions about Argus and/or CAPAs, feel free to reach out.

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Rodney Lemery

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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