Validating corporate computer systems

Posted by / 01-May-2019 02:33

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.

validating corporate computer systems-37validating corporate computer systems-34validating corporate computer systems-50

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.

One thought on “validating corporate computer systems”

  1. The salient-seeming text arrives, and evaporates like rising steam, pushed into the abyss beyond my screen by more incoming i Message bubbles of instructions about S’s street address, the lockbox code to get the keys to her apartment, how to locate her room, disclaimers about the room’s condition (), etc.

  2. On our second date, my wife and I went to a bookstore and browsed together while having coffee, which naturally brought up shared interests and opportunities for conversation.