Process
Areas
(staged)

Level 2
 
REQM
 PP
 PMC
 SAM
 MA
 PPQA
 CM
Level 3
 
RD
 TS
 PI
 VER 
 VAL 
 OPF
 OPD
 OT
 IPM
 RSKM
 DAR
Level 4
 
OPP
 QPM
Level 5 
 
OPM 
 CAR

      5. Process Areas
          5.21. Validation
 SG 1 Prepare for Validation 
Process AreaVAL
Level3
GoalSG 1

Preparation for validation is conducted.

Preparation activities include selecting products and product components for validation and establishing and maintaining the validation environment, procedures, and criteria. Items selected for validation can include only the product or it can include appropriate levels of product components used to build the product. Any product or product component can be subject to validation, including replacement, maintenance, and training products, to name a few.

The environment required to validate the product or product component is prepared. The environment can be purchased or can be specified, designed, and built. Environments used for product integration and verification can be considered in collaboration with the validation environment to reduce cost and improve efficiency or productivity.




Process
Areas
(continuous)


Process
management  
 
OPF
 OPD
 OT  
 
OPP  
 OPM

Project
management
 
PP
 PMC 
 REQM 
 
SAM  
 
IPM
 RSKM
 
QPM

Engineering
 
RD 
 TS
 PI
 VER 
 VAL
Support
 
CM
 PPQA
 MA
 
DAR
 CAR