Audit Core Matrix – Device CGMPs Documentation Review:  Systems, SOPs, records, et al, (references are to 21 CFR Part 820, Quality System Regulation:

 

Subpart                Description                                                     Reviewed (‘Y’ or ‘N’) / Comments

 

  A                           General (820.1, -.3, -.5)  

  B                           Quality System Requirements    (820.20, 

                                -.22, -.25)

  C                           Design Controls (820.30)                

  D                           Document Controls (820.40)       

  E                           Purchasing Controls (820.50)      

  F                           ID and Traceability (820.60,  -.65) 

  G                          P and PC (820.70, -.72, -.75)                                                        

  H                          Acceptance (820.80, -.86)              

  I                           Nonconforming Product (820.90) 

  J                           CAPA (820.100) 

  K                          Labeling and Packaging Control (820.120

                               -.130)                

  L                          Handling, … (820.140, -.150, .160-.170)                                                         

  M                         Records (820.180, -.181, -.184, -.186, -.198)                                                         

  N                          Servicing (820.200) 

  O                          Statistical (820.250)

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