1. Quality Management
Documents & Templates
FDA 21 CFR 820 Quality System Regulation
Compliance Checklist
• Are you using a protocol for this validation (defined
operating conditions)?
• Are you using initial production units, lots, or batches?
• Are units tested under simulated use conditions?
• Was software validation included?
• Was Hazard (Risk) Analysis performed?
• Is this process documented in the DHF?
5.11 Design Transfer
• Is there a procedure that controls/ensures device design
is correctly translated into production specifications?
• Is there a formal process to ensure this transfer (such as
development report or product transfer team)?
Design Changes
Are there procedures ensuring identification documentation
validation, verification, review and approval of design
changes before their implementation?
5.12 Design History File
Do you have a Design History File for each type of device?
Does the file contain:
Design review minutes
Design verification and validation protocols and reports
Design transfer documentation
Customer Comments on Section:
820.30
Document Type Document ID Version Status Page
SOP XX_WWW_ZZZ_YYYY 1.0 Approved 10/24
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