When Should Validation Begin in Regulated Projects?

The mistake that still causes rework and delays in CSV, Process Validation, and Cleaning Validation

Many companies still believe that validation only begins during the testing phase. In practice, however, this is one of the most costly mistakes in regulated projects.

When validation is introduced late in a project, the consequences often include:

  • Rework;
  • Repetition of studies;
  • Delays;
  • Increased costs;
  • Regulatory risks.

The reality is that validation starts long before testing begins.

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What You Will Learn in This Video:

  • When validation actually begins;
  • How this applies to Computerized System Validation (CSV), Process Validation, and Cleaning Validation;
  • The concept of Process Design;
  • The role of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs);
  • The most common mistakes that create bottlenecks in regulated projects.

Watch the video to understand the complete rationale and see practical examples.

Why Does Validation Often Start Too Late?

In many organizations, validation is still treated as a final approval activity.

  • The process has already been defined
  • The system has already been implemented
  • And only then does validation begin.

The problem is that when requirements and risks are not identified from the start, testing often reveals issues that could have been prevented much earlier. This is exactly where the following begin:

  • Project reviews;
  • Test redesign and repetition;
  • Late-stage adjustments;
  • Regulatory delays.

The Principle That Changes Everything

Regardless of the type of validation, they all follow the same fundamental logic:

First: understand the process Then: confirm that it consistently performs as intended.

This principle applies to:

  • Computerized systems

  • Manufacturing processes

  • Cleaning processes

  • Equipment

  • Analytical methods

  • Any system that impacts product quality

    In the video, we explain how this concept is directly connected to the modern validation approach adopted by the FDA.

    Watch the video

    Frequently Asked Questions - FAQ

    Does validation begin during testing?
    No. Validation begins during the development and design of the process or system.
    What is Process Design?
    Process Design is the phase in which scientific process understanding is established and critical parameters are defined.
    Why does starting validation late create problems?
    Because it increases the likelihood of:

    • Rework

    • Repeated studies

    • Delays

    • Documentation revisions
    Does this concept apply only to Process Validation?
    No. The same principle also applies to Computerized System Validation (CSV), Cleaning Validation, Equipment Qualification, and Analytical Method Validation.
    What is Quality by Design (QbD)?
    Quality by Design (QbD) is an approach that aims to build quality into a process from the very beginning through scientific understanding and risk management.