With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
Using advanced technology still requires validation.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
Not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.