ERP validation

Hi All,

I am new to this forum and i feel very lucky to be a part of this forum.

We would like to implement software validation process in our company (ie) we would like to apply section 6 of General Principles of Software Validation; Final guidance for industry and FDA staff.

We are medical device manufacturing company and we have been using some automated machines for process and ERP for quality management system. Kindly help to understand software validation and how to conduct validation for ERP package.

Thank you

Cinti

Hi Cinti

We are currently developing a new software validation e-learning module that will be on sale soon here so keep a look out.

If you would like help with your validation project our sister validation company would be glad to help. Premier Validation

For a fist understanding see Good practices for computerized systems in tregulated gxp environments: ISBN3-934971-19-9.

If there are detailed questions, don`t hesitate…

Rgds

gtf