Analytical Method Validation

Be confident your analytical methods support informed decision-making with precise, accurate, and stable data.

Benefits this Solution Provides

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Evaluate Performance Effectively

Control the uniformity, stability, and reliability of your analytical methods.

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Eliminate Human Error

Implement paperless protocols and test execution with integrated deviation workflows.

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Control Risk

Use systematic risk assessment models to determine sampling requirements.

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Achieve Compliance

Guarantee compliance with 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.

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Enforce Standards

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  • Eliminate the inefficiencies caused by disparate procedures by creating risk assessments and protocol standards that provide consistency across the lifecycle.
  • Facilitate the controlled assessment, testing, and documentation of a method’s suitability for intended use. 
  • Automate task scheduling and notification with approved protocol and testing workflows. 

Enjoy Multi-Site Visibility

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  • Manage all site data and test results in a single repository that retains all your instruments and equipment data, documentation, evidence, and batch records.
  • Perform diagnostic testing and compare site results to determine the most accurate and effective methods. 
  • Collaborate in real time across different sites and time zones. 

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Defend with Traceable Documentation

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  • Demonstrate detection capability and limits of detection (LOD) with auditable test results that flag out-of-specification deviations.
  • Author, review, approve, and execute protocols using a fully digital, intuitive validation process.
  • Easily retrieve associated documentation, risk assessments, and test results to support your analytical methods. 

What Can You Expect From Implementing Our Solution?

Before After
Manual document authoring and execution processes are time-consuming. Digital processes reduce cycle times by up to 50%.
A manually created traceability matrix becomes unwieldy as design progresses, making it difficult to demonstrate closed-loop traceability. Trace matrix generation occurs dynamically, and connections and impacts are recorded in real time, making it easy to demonstrate the relationships that prove product safety and efficacy.
Omissions, delays, and missed deadlines are common due to a lack of standardization. Enforced standardization and automatic task assignments and notifications limit errors and oversights.
Disparate tools and systems create data silos that impede document retrieval and visibility. A single digital repository gives users immediate access to critical data and documentation.

Learn More From Our Experts

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Blog Post

Process Lifecycle Management

Optimizing Your Annual Product Quality Reviews

Read the Blog Post


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Industry Insight

A Roadmap for Implementing Analytical QbD

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Webinar

Digital CQV and Pharma 4.0: Paving the Way for Future Success

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Talk to us to see how ValGenesis can support your digital transformation.