
The Benefits of Automating Your Requirements Traceability Matrix
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.
Nov 17, 2022 1:00:00 PM | Philips needed a digital validation system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.
Philips needed a digital validation system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.
New Science can deliver accessible, affordable, and transformative patient outcomes when built on well-defined outgrowth strategies that access emerging technologies.
“CPV is a broader concept because it gives you a more holistic picture of overall product performance over a period of time. While both APR and CPV give you an indication of product performance, the current situation in most companies is that they remain disconnected".
Roche/Genentech eliminated 50% of the non-value-added paper-based tasks employees were forced to perform and reallocated resources to prioritize innovation.
Digitalization and the Pharma 4.0 vision appeals to young generation engineers from ‘career development’ and ‘cultural engagement’ perspectives.
The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, says FDA.
Faster innovation and time to market are top priorities for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.
We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework
ROI study reveals how much time and money customers save by digitizing corporate validation processes. Watch the webinar (link in post).
When manufacturers rely on paper-based logbooks, they expose themselves to human errors, poor data integrity, and a host of compliance risks.
Root-Cause Analysis
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
Written by
Sofia Santos
Process Digitalization
How to Accelerate Process Scale-Up With Effective Tech Transfer
There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
Written by
Sofia Santos
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.
Discover how digital cleaning validation strategies can modernize established pharma facilities, ensuring compliance, efficiency, and patient safety.
Previously
Is Your Cleaning Validation Stuck in the Slow Lane?
Cleaning Validation Program Compliance: Build a Framework for Success
Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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