Validation Plan

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