Mi problema es con deliverables 19:10 Feb 19, 2005
VALIDATION DELIVERABLES
This section describes the required deliverables and prerequisites for this project. A Validation Deliverables Matrix table is also provided.
1) Core Validation Deliverables
The following describes the Core Documentation Deliverables required for the TCMS project
a) Regulatory Assessment
The letter of notification is used to formally notify the Group Vice President of GCA that the Program Management has assessed the implementation XRV system impact upon regulated current GMP and therefore requires validation.
b) Global Validation Plan
The Global Validation Plan (this document) provides a description of the process by which the system will be validated. The validation deployment scenarios outline the overall plan for the core system implementation, the site deployments of the XRV application, Batch Printing functionality, and Webcache.
2) Site Deliverables
Defines the Site Documentation Deliverables required for the XRV system validation.
Responsibilities for site creation, approval and review, and final deliverable storage locations are defined by applicable site procedures. All Site Documentation Deliverables will be maintained per site procedures.
a) Site Document Migration Plan
The Site Document Migration Plan defines the strategy for migrating existing site documents into the system, maintaining the integrity and accuracy of the information within the document content as required and supporting existing business processes for the specific site. After validation has been completed at the site and access to use the system in production has been granted, existing documents will be imported into the XRV system as electronic document files (e.g., Microsoft Word format). Only the current version of documents will be imported.
Site Training
Approved Central Training Materials for the XRV system will be provided to the implementing sites. Site personnel executing validation testing shall be trained on the Global Content Management system and on any pertinent SOPs governing validation execution. | 
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