Analytical Method Validation

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

Benefits this Solution Provides

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

Implement paperless protocols and test execution with integrated deviation workflows.

Use systematic risk assessment models to determine sampling requirements.

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

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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.