Software Validation Checklist

Computer system validation and maintenance checklist

Introduction Letter for the software validation cheklist (part of the document template):

"As an integral part of our company quality system and to comply with current GxP regulatory requirements, we would like to evaluate your company’s quality and regulatory profile.
This formal assessment was created to evaluate computer system validation cGxP compliance and assess the effectiveness of your quality system. This checklist collects information on various aspects that may impact our products and procedures.
Your provided information will be treated as highly confidential. We further declare that we use the information only, for the sole purpose of making a decision as weather to enter a trading relationship with your company.
We will protect your information from use by any other party, except as law might require it.
Please enter the answers or requested data into the attached compliance checklist and certify by signing the last page the completeness and accurate reflection of practices by your Quality function.
With the signature on the last page we regard your response as a legally binding part of any decision we make to deal with your company. In the event that the provided responses are not accurate, we may consider such responses to be the cause for re-evaluating, or terminating a trading relationship.
We expect your consent with reasonable advance written notice to inspect your company on site to assure the operations are in accordance with cGxP and do get access to relevant documentation.

If you have any questions or concerns regarding any of the questions, or any other aspect of the questionnaire itself, please do not hesitate to contact us."


Page Example:

Software validation

 

This checklist is in compliance with European and US GMP Standatds.

For SOPs go back to the mainpage.


Copyright 2011 by Standard Operating Procedure

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