PLAN: Prepared 2/17/2003

 

Reason for Validation (New software, software upgrade, hardware upgrade, other): Upgrade

 

Rationale for Change (if upgrade or new version, also include vendor’s summary of version differences or reference to where it can be found):

·          Enhanced functionality 1

·          Enhanced functionality 2

·          Enhanced functionality n

 

Hazard Analysis:

[perform hazard analysis, determine level of risk, equate that to validation/qualification level]

 

Software Information

1.        Software Title

COTS

2.        Version Number

4, Level 1.1

3.        Mfg. Name

COTS, Inc

4.        Mfg. Contact, if any

 

Mary Jones

123 Street, Suite 395

Anytown, USA

1-800-555-1234

1-999-555-5678 (fax)

5.        Release Date

January 15, 2003

6.          Documentation (user manuals): provide list and where stored

Support for the user consists primarily in a series of documents:

 

·          Users Guide I – COTS Users Basic Guide

·          Users Guide II – COTS Users Supplemental Guide

·          Users Guide III -- COTS Installation Guide

 

Hard copies are available in the library.  For online help, users can enter ‘COTSHELP’, from a terminal window.

7.          Known limitations/errors

See Known Bugs section in COTS validation map. [link to page]

8.          Vendor’s Validation Statement or Certification

 

Vendor Statement

[link or attach vendor validation statement]

 

[Your Name Here] Statement

[link or attach your validation statement]  

 

Project Plan

 

Task

Date

Responsibility

Validation Protocol: Plan & Qualification

2/17/2003

Jane Doe

Installation Qualification

3/3/2003

John Smith

Operational Qualification

3/4/2003

Adam Sandler

Performance Qualification

3/4/2003

John Smith

Documentation of Results

3/4/2003

Buffy Summers

Validation Summary

3/7/2003

Jane Doe

Effectivity Date

5/8/2003

Jane Doe