Validating corporate computer systems
Our computer system validation experts have validated computer programs for all types of FDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories.
Computer validation is more than a compliance requirement.
The result is increased employee efficiency and your company is now more productive.
Isn’t that why you bought the computer system in the first place?
Computer System Validation: Step-by-Step Learn computer system validation essentials and eight fundamental steps of implementation for cost saving.
Get complementary SOPs and checklists for easy implementation.
We staff projects based on required expertise and scope, providing the most efficient and cost effective CSV services possible.
"As your consultant I will provide personalized service for each member of your team so they learn how to work together and with computer systems to maximize productivity.
This means the system is up and running with trained users in a third of the time too.
Basic Requirements Computer system validation requires, first, that you obtain or design a process that can consistently conform to requirements; and then that you run studies demonstrating that this is the case.
Both tasks can be performed with the aid of the right statistical tools.
FDA: Examples of Computer Systems The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." The objective of validation, therefore, is to produce documented evidence that parts of the facility will work correctly every time, when brought into use.
The goal is also to make sure that quality is built in to the system at every step; and not just a factor at the 'output' end of the process chain.
To evaluate a simple method to establish system risk level, Read More FDA Compliance and Clinical Trial Computer System Validation This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation.