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ValGenesis Blog

The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry.

July 13, 2021

Cleaning Validation Stage 2: Performance Qualification

The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.

June 16, 2021

Cleaning Validation Stage 1 – On a Quest for Process Understanding

The key to control for any process resides in the understanding of its variability. How much do we know about the variation of our processes or systems and are we in the state of control? These questions require answers to achieve success in the execution of the Equipment Cleaning Process.

April 13, 2021

Hands-Free Validation

Hands-Free Validation is the ability to perform validation tasks with no-or-low touch. In some instances, 100% Hands-Free Validation is possible and, in fact, recommended. This is especially true now during the COVID-19 pandemic where the need to eliminate exposure and transmission is the desired objective.

May 29, 2020

FDAs Computer Software Assurance (CSA) – Part 3 of 3

The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.