MONTRIUM

MICROSOFT SHAREPOINTTM 2013 QUALIFICATION

PACKAGE

2014

8/7/2014 Private and Confidential

 Microsoft SharePointTM 2013 Qualification Package

1 MICROSOFT SHAREPOINTTM 2013 QUALIFICATION PACKAGE

The table below presents the list and description of the documents included in the Microsoft
SharePointTM 2013 Qualification package.

Document Type Document Purpose

Regulatory Impact Assesses the regulatory impact of using the application and identifies the areas of the system
Assessment that pose the highest risk and must be validated in order to demonstrate compliance with
applicable pharmaceutical regulations. (This document may typically be included as an
appendix to the Validation Plan).
Qualification Plan Outline the validation approach, activities, responsibilities and deliverables for of Microsoft
TM
SharePoint 2013 for electronic records management.
Requirement Describes the user and functional requirements of the various elements of the solutions.
specifications
Functional Describes the system functionality which allows it to function according to user requirements.
Specification
Configuration Defines all parameters for sites, content types, columns, libraries/lists and security for the
Specification solution. This configuration specification will be provided in the form of Design and
Configuration Workbook (DCW) that can be leveraged to manage system configuration
baseline throughout the system lifecycle.
Deployment Guide Describes how the solution can be deployed in the intended environment in a reproducible
fashion.
IQ Protocol and Govern the verification of system installation to provide documented evidence that the system
Scripts is installed correctly.
IQ Report Report the results obtained during execution of the installation qualification (IQ) test scripts.
OQ Protocol and Govern the operational testing, which verifies that user’s requirements are met and the
Scripts system is fit for its intended use.
Requirements Traces user requirements to system testing to ensure coverage.
Traceability Matrix
Qualification Summarize the entire qualification effort as well as its outcome. Authorize the release of the
Summary Report system for Production use.

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