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How to Overcome the Subjectivity of Objective Evidence in FDA Audits

Jul 20, 2023 10:00:00 AM | How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.

Posts about Validation Software:

How to Overcome the Subjectivity of Objective Evidence in FDA Audits

How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.

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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 Pharma 4.0 Vision for Manufacturing Intelligence

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