Applying ISPE Baseline Guide 5 to a Paperless Validation System

Pharmaceutical Manufacturers are required to demonstrate facilities, systems, utilities, and equipment are suitable for the intended purpose. The ISPE Baseline Guide 5 (Second Edition) provides ‘best of the best’ practical guidance on the implementation of a science and risk-based approach for Commissioning and Qualification (C&Q). As the pharmaceutical industry adopts paperless validation systems for C&Q, understanding how to employ Baseline Guide 5 in paperless C&Q processes presents unique challenges.

During this webinar, understand:

• key principles of the ISPE’s Baseline Guide Volume 5
• how Kneat supports a risk-based approach to validation
• explore key features and functionality of Kneat

Our Speakers – No Deviation
Founded in 2007, No Deviation delivers patient centric process and engineering solutions to pharmaceutical, life sciences, food and beverage, and medical technology industries companies, delivering value-added commissioning, qualification and validation services as leading experts in lean CQV methodology.