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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.

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Medical Device Risk Management: Should You Digitalize Your Process?

Nov 28, 2024 1:13:07 PM | Transform medical device risk management by digitalizing processes, improving compliance, efficiency, and collaboration while reducing errors and audit challenges.

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A medical device with a touch screen displaying vital signs and controls, next to a ventilator and a pulse oximeter

Medical Device Risk Management: Should You Digitalize Your Process?

Transform medical device risk management by digitalizing processes, improving compliance, efficiency, and collaboration while reducing errors and audit challenges.

A person is overwhelmed by physical logbooks, while a tablet showcases the organized interface of electronic logbook software.

Access Your Logbook Data Instantly with ValGenesis e‑Logbook

Transform your logbook data into a strategic asset with ValGenesis e-Logbook for enhanced compliance, decision-making, and operational efficiency.

A pharmaceutical technician oversees a conveyor belt carrying vials of medication. The technician is using a tablet to monitor the production process, demonstrating the integration of technology in modern pharmaceutical manufacturing.

Validating Pharma 4.0 for Smart Manufacturing

Explore how Pharma 4.0 leverages advanced technologies to revolutionize pharmaceutical manufacturing, enhancing efficiency, quality, and patient-centric outcomes.

A diagram highlighting the importance of Control Strategy within the broader Knowledge Space. The

Building Control Strategies: It's Time to Go Digital

Discover the steps and benefits of digitalizing control strategies in pharma manufacturing to enhance compliance, efficiency, and product quality.

Move Beyond Manual CQV Challenges with Digital Solutions

Discover how digital CQV with ValGenesis VLMS streamlines compliance, cuts costs, and boosts efficiency, supported by customer metrics that demonstrate measurable ROI.

What is a Multi-Site Digital CPV, and Why Should You Want It?

A Multi-Site Digital CPV system allows you to manage and monitor manufacturing processes across multiple sites in real-time.

Tablet computer showing a product changeover log in a digital cleaning validation solution

How Can Digital Cleaning Validation Improve Product Changeover Safety?

Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.

 A person clears a hurdle, symbolizing quick and easy software setup for computer software assurance.

Out-of-the-Box Computer Software Assurance with ValGenesis

Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.

A woman pointing at a digital interface with a checklist of software requirements and colored indicators of risk levels.

Requirement-Level Risk Assessment: A Game-Changer in Validation

Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.

Three stopwatches showing a countdown, with the last one sounding an alarm.

Mastering Equipment Hold Time Controls with Electronic Logbooks

Optimize pharma manufacturing with ValGenesis e-Logbook for automated clean/dirty hold time management. Ensure compliance, efficiency, and patient safety.

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Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

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.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

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.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

Trending Topics With ValGenesis Customers

CSV and the Shift to CSA

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.

Previously

Requirement-Level Risk Assessment: A Game-Changer in Validation

Rethinking Validation: Why CSV Falls Short for Agile Teams

Cleaning Validation

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.

Previously

Avoiding Common FDA 483 Observations in Cleaning Validation

What are the Regulatory Expectations for Cleaning Validation?

Pharma 4.0

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.

Previously

The X Factor for Successful Digital Transformation in BioPharma: People

The Pharma 4.0 Vision for Manufacturing Intelligence

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