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Validation by Design a.k.a Validation 4.0 transforms the way the validation is traditionally performed. Applying Validation 4.0 (Validation by Design) will require to adopt a new way of thinking and working as the system requirements should be verified during it development, configuration and implementation.

The validation by design incorporates the Computer Software Assurance (CSA) which is a risk-based approach for establishing and maintaining confidence that the computer system is fit for its intended use.

Validation by Design

The Validation activities should take place through the process design and product development that establish a correlation between the Definition of Requirements, Validation Process and Data Lifecycle with a solid Risk Based Approach.

“The goal of Validation 4.0 is to develop a cohesive, harmonized, integrated, holistic, risk-based approach for process performance qualification incorporating computer system validation that builds on the Pharma 4.0™ operating model and includes the holistic control strategy, digital maturity, and data integrity by design.”

Mivado GlobalPerformance will apply its 3-Stages Approach to System Validation call Validation by Design:

Stage 1: Requirements Development & Design

This Stage 1 is based on product, process and data flow understanding including system classification, System boundary, critical quality attributes (CQAs) and relevant regulatory requirements:

  • System requirements development
  • Functional Requirement Specification
  • Quality Risk Assessment
  • Quality critical requirements
  • Validation Planning phase deliverable

Stage 2: Performance Qualification & Validation

In this Stage 2, System knowledge and understanding coupled with risk-based approach are the key to determine if the system performs as expected:

  • Requirements Risk Assessment
  • Access control Strategy
  • Supplier Assessment Review
  • System knowledge and understanding
  • Data Flow and Data Integrity
  • Qualification and Testing Documentation

Stage 3: Continued System Verification & Validation

This stage 3 shall put in place all necessary activities that need to be executed throughout the operational life of the system to verify that it remains compliant with regulatory requirements:

  • Periodic Review
  • System Preventive Maintenance Program
  • System intended use
  • Re-qualification Policy
  • Re-Validation Processes

To ensure that the products are absolutely fit for intended use, the company has to demonstrate in a documented form that the processes, methods, tests, activities and equipment they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. The validation activities have been categorized into following parts:

3-Method Validation

6-Transportation Validation

Mivado GlobalPerformance is the industry leader in validation activities. Our experienced validation team will document the consistency, quality, and accuracy of your devices, equipment, systems, methods, and processes.

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