In
response to procurement and bidding activities, vendors and subcontractors
prepare and
submit infromation regarding the facilties, equipment, and
utility systems to be installed during
the conruction phase of a GMP
project...
This information must be carefully reviewed and approved
against the requirements and
specifications....
This information
accompanies the items to the field in the form of Engineering Turn-over
packages (ETOPs) and Vendor Data...
Copyright 2004-08
Information Flow...during
Construction
|
cGMP
Compliance...How information gets around...
|
Regulated Facilities
and
Processes
Engineering
Project
Management
Commissioning
Qualification
How
does information move from the Construction Team to the Engineering and
Compliance
Teams?...
All
Rights Reserved
Submittals and
Vendor Information
|
Click on the image
at left for a diagram describing information flow from
submittlals to the Engineering and Compliance Teams...
|
Need
specific examples of type of information to be incorporated into ETOPs and
construction
documentation...
Construction information follows
field operations and represents the accumulated
documentation of field
construction activies...
Click on the image
at left for a diagram describing information flow from field construction activities to Engineering and Compliance
Teams...
|