Software validation for a document control system

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

I work in the medical device manufacturing industry. I have recently taken over the software administrator position and have been tasked with validating the system upgrade (with no prior experience). We are using a QMS system for managing our documents and will be using electronic signatures. The software is OTS, configurable and workflow based. I was hoping to use the information from the initial validation but was told by a consultant that it would never pass an audit. I couldn’t follow it and neither could the consultant. So, here I am spinning my wheels trying to read everything I can, there is a lot of great information here, I also purchased the GAMP5 and it is very helpful. My question is can anyone provide me with a software validation URS sample that I can use to get started. Also, should I do the URS before I do the risk assessment, no risk assessment was initially done.

Thanks,
Kate

2

Hi Kate,

         Please go through the link

http://www.ispe.org/index.php/ci_id/18865/la_id/1.htm
.

         The SCADA sample URS and the document on risk-based approach may be of help to you.

Brs

Subhajit.

3

Thank you Subhajit this is very helpful.

4

Here we also working like you , But i am also a programmer and make a software for our admin and accounts section. Now going good in this software. What facilitates need you ? I make all. Now i called id Administrator Accounts software.