Computer Systems Validation

Many companies are looking at certifying their computer systems. What I mean by this is that they want to ensure they are receiving accurate information from their systems in comparison to the information being entered.

What is Computer Systems Validation?
Validation is the ability to prove that your software is functioning in the manner in which it was designed. In addition, you will also prove (with documented evience), that you are receiving the results from your systems that you expect to receive.

What is involved in Validating a computer system?
Below is a diagram which outlines the steps involved in the validation of your computer systems. If you have any questions on this process or would like to take the next step, send us an e-mail.

Why should I validate my computer systems?
There are a number of reasons to validate your computer systems :

• ISO Certification
• FDA Requirements (21 CFR Part 11)
• TPD Requirements (GMP Compliance)
• Or maybe you just want to make sure that your system is living up to it's expectations.

At Gothic Fusion, we have the experience and tools to assist your company in the successful validation of your computer systems.

For more information about Computer Systems Validation, please contact us today.