21 CFR Part 820 / QMSR · Subpart M

Records

The device master record, the device history record, the quality system record and complaint files, plus confidentiality and retention. The four record sets that between them evidence the whole system.

What you will be able to do

Distinguish the device master record from the device history record
Run a complaint file that meets the review and investigation requirement
Apply retention periods tied to the design lifetime of the device

What the package includes

Full-length training video, presenter-led
Presenter script
Companion handout for the subpart
Ten-question graded assessment
Audit-ready SOPs for the subpart
Fillable records and supporting documents

Listed runtime 30 minutes. Which materials open on your account depends on the plan you hold.

Watch this module on the free trial

The three-day trial opens the first six modules of 21 CFR Part 820 / QMSR on screen. No card, and nothing converts automatically.Start the 3-day trial See pricing