Streamlining Computer System Validation (CSV) – a risk-based approach for Life Sciences Manufacturing and Labs
Posted on July 14, 2021 by Helena Graham
Written by Brendan Walshe, Senior Validation CSV Consultant, Zenith Technologies, a Cognizant Company and Henal Shah, EU Lab CoE Practice Head, Cognizant. New Whitepaper Available here
The Life Science industry has a strong legacy of Validating Computer Systems thoroughly. However, the traditional ‘test everything approach’ has become outdated and leaves GMP manufacturing facilities spending more time documenting than testing. Traditional CSV methodologies can see manufacturers spending up to 80% of their time documenting processes, and only 20% of time testing the efficacy of the solutions.
An industry shift in validation practices is happening, as Life Sciences clients’ successfully embrace a ‘risk-based Computer Systems Validation (CSV) approach’. Through this shift in focus, clients have reported improved product quality and speed of delivery, as well as cost and time savings.
In this newly published whitepaper we highlight how a shift in mindset can deliver business and patient benefits through streamlining CSV.
We examine a risk-based approach that focuses its strategy on the following questions:
- Is the software going to impact the patient’s safety?
- Is it going to impact product quality?
- How does it impact data integrity and quality assurance?
This paper also illustrates the industry’s appetite for change and the approaches that will facilitate such a change in a Manufacturing and Laboratory environment. Finally this paper also focuses on how accurately testing the critical aspects of a system, reduces unnecessary documentation time, and increases value delivery time, thus reducing the cost of deployment.
About the Authors:
Brendan Walshe, Senior Validation CSV Consultant, Zenith Technologies, a Cognizant Company
Brendan Walshe, current role is Senior Validation and CSV Consultant working in the Cognizant Life Sciences Manufacturing Business Unit. He has more that 20 years of Validation experience across the Pharmaceutical, Medical Device and Biopharmaceutical Industry. He currently supports the global consultancy group in developing and implementing CSV strategies for our Life Science Sector clients. He is a seasoned CSV SME and has held various strategic roles on multiple projects within the Life Science sector. He also has strong experience in developing and implementing CSV programs for clients and in Validation planning.
Henal Shah, EU Lab CoE Practice Head, Cognizant.
Henal Shah currently plays European Lab Centre of Excellence (CoE) Practice Head role in the Life Science ISG Manufacturing group within Cognizant. She has more than 20 years of experience in multiple sectors including Life Sciences, Manufacturing, Retail, Insurance, Travel and Hospitality and Trade Finance. She has led Life Sciences Quality Engineering and Assurance practice within Cognizant UK& Ireland for the past 11 years in the capacity of GxP Validation, Testing and Compliance SME across Life Sciences value chain ie. Discovery, R&D, Manufacturing and Pharmacovigilance areas. In her past stint in the UK & US, she has led multiple Infrastructure, ERP, Veeva, LIMS, and other Lab/Quality systems implementations/test consulting validation, GxP compliance engagements within Cognizant Life Sciences(LS) for R&D and Manufacturing portfolios.. Having worked with the Life Sciences domain for the past 15 years, she is a seasoned CSV, Compliance, Testing, Quality Assurance SME and has played various strategic/delivery roles in complex integration programs in Merger & Acquisitions, SAP Validation, Medical device R&D IT and Manufacturing areas. She also has strong experience implementing LIMS in various Pathology Labs in USA. She is Azure Cloud, Azure AI/ ML and TOSCA Test Automation certified professional.