The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry.
November 10, 2021 | The episode "Digitization Of Validation For Effective Virtual Regulatory Inspections", originally broadcast on IVT Network's Voices in Validation podcast won the 2021 Voices in Validation Podcast of the Year Award. The episode featured Dr. Ajaz Hussain, Dr. Alton Johnson and Steve Thompson.
The final and the longest stage of validation is Stage 3, which encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently. It is also known as continued verification process or CPV.
Paperless validation systems were introduced to the industry 10 years ago. Early in the lifecycle of these technology paperless validation system provided standard document management and electronic execution capabilities.
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.
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.
Saving bottom-line costs of paper and paper storage is just one benefit of paperless validation. Also at stake: disaster recovery, using big data intelligently, and keeping remote teams productive.
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.
In the on-going COVID-19 pandemic, the U.S. Food and Drug Administration has postponed domestic and foreign routine surveillance inspections on a case-by-case basis; it is prioritizing mission-critical inspections that it seeks to conduct with appropriate safety measures in place.
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.
Digitization, synonymous with digitalization, is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology.
