Analytical Method Validation

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

Benefits of Analytical Method Validation

Evaluate Performance Effectively

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

Eliminate Human Error

Implement paperless protocols and test execution with integrated deviation workflows.

Control Risk

Use systematic risk assessment models to determine sampling requirements.

Achieve Compliance

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

Enforce Standards

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

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.

Defend with Traceable Documentation

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.

The Value of Analytical Method Validation

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.

Before

Manual document authoring and execution processes are time-consuming.

After

Digital processes reduce cycle times by up to 50%.

Before

A manually created traceability matrix becomes unwieldy as design progresses, making it difficult to demonstrate closed-loop traceability.

After

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.

Before

Omissions, delays, and missed deadlines are common due to a lack of standardization.

After

Enforced standardization and automatic task assignments and notifications limit errors and oversights.

Before

Disparate tools and systems create data silos that impede document retrieval and visibility.

After

A single digital repository gives users immediate access to critical data and documentation.

Learn More

Blog Post

Best Practices for Process Validation in the Pharmaceutical Industry

Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.

Read the Blog Post

Industry Insight