CAPA Regulatory Requirements & Standards 2

Question 1

Under 21 CFR Part 820, what is the minimum timeframe a manufacturer must retain CAPA records?

Accepted Answer

2 years from the date of approval or release of the device

Answer

21 CFR 820.198 and 820.100 require records be retained for a period equivalent to the design and expected life of the device, but not less than 2 years from the date of release.

Question 2

Which ISO 13485 clause specifically mandates CAPA procedures for medical device manufacturers?

Accepted Answer

Clause 8.5

Answer

ISO 13485:2016 Clause 8.5 covers improvement, including corrective action (8.5.2) and preventive action (8.5.3) requirements.

Question 3

In an FDA inspection, an investigator finds a CAPA was closed before verifying effectiveness. This most likely violates which 21 CFR 820 requirement?

Accepted Answer

820.100(a)(7) Verifying or validating corrective and preventive action

Answer

21 CFR 820.100(a)(7) explicitly requires manufacturers to verify or validate corrective and preventive actions to ensure effectiveness before closure.

Question 4

How does EU MDR 2017/745 differ from the previous MDD regarding CAPA in post-market surveillance?

Accepted Answer

EU MDR requires more rigorous and proactive PMS with periodic safety update reports linking to CAPA

Answer

EU MDR 2017/745 mandates robust post-market surveillance systems with Periodic Safety Update Reports (PSURs) that must actively link findings to CAPA activities.

Question 5

Which standard provides guidance for complaint handling that directly feeds the CAPA process in medical device companies?

Accepted Answer

ISO 13485:2016 Clause 8.2.2

Answer

ISO 13485:2016 Clause 8.2.2 covers feedback and complaint handling, which serves as a primary input source for triggering CAPA investigations.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Regulatory Requirements & Standards 2