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TEM-165 Design Qualification Protocol Sample

The document outlines the steps for a project specification and validation plan, including generating a user requirement specification, QA review and approval of the specification, supplier audit, confirming the functional specification and related project specifications, design review, HAZOP analysis, risk assessment, impact assessment for computerized systems with reference to FMEA, safety audit, commissioning and qualification plan, factory acceptance testing, site acceptance testing, and creating a validation plan.

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144 views1 page

TEM-165 Design Qualification Protocol Sample

The document outlines the steps for a project specification and validation plan, including generating a user requirement specification, QA review and approval of the specification, supplier audit, confirming the functional specification and related project specifications, design review, HAZOP analysis, risk assessment, impact assessment for computerized systems with reference to FMEA, safety audit, commissioning and qualification plan, factory acceptance testing, site acceptance testing, and creating a validation plan.

Uploaded by

baluchakp
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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U s e r R e q u i r e m e n t

S p e c i f i c a t i o n g e n e r a t e d .

Q A r e v i e w a n d a p p r o v a l o f
U R S

S u p p l i e r A u d i t .

C o n f i r m F u n c t i o n a l
S p e c i f i c a t i o n a g a i n s t U R S

C o n f i r m o t h e r r e l a t e d

P r o j e c t S p e c i f i c a t i o n s .
D e s i g n R e v i e w

H A Z O P

R i s k A s s e s s m e n t o n
P r o d u c t Q u a l i t y

I m p a c t A s s e s s m e n t f o r

C o m p u t e r i s e d S y s t e m .
R e f e r
F M E A

S a f e t y A u d i t

C o m m i s s i o n i n g a n d
Q u a l i f i c a t i o n P l a n
F a c t o r y A c c e p t a n c e t e s t i n g

S i t e A c c e p t a n c e t e s t i n g

C r e a t e V a l i d a t i o n P l a n

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