Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
- Document a computer system validation project using easy to understand fill-in-the-blank templates.
In this role, he was instrumental in establishing the company's expertise in
computer system validation and 21 CFR Part 11 compliance.
Computer system validation (CSV) is a primary goal in the verification of performance, quality and data integrity for any system that falls under regulatory requirements provided by the Code of Federal Regulations and is subject to 21 CFR Part 11 compliance.
Implementing a Manufacturing
Computer System ValidationThe regulator is also organizing joint workshops with FDA in different cities to exchange updates in various aspects of GMPs like process validation,
computer system validation etc.
IS YOUR ORGANIZATION READY FOR an inspection of your Computer System Validation program?
Another important piece to include is the location of the computer system validation documentation, as this is not only important from a storage aspect, but also an access point of view.
It is notable to mention there are an increasing amount of 483s and Warning Letters for companies failing to exercise change control and perform computer system validation for their respective systems.
Deploying good documentation practices helps ensure the integrity of your computer system validation and change control documentation.
It encompasses the use of established practices that include, but are not limited to written standard operating procedures (SOPs), audit reports,
computer system validations, and training records.