Validation by Design, a.k.a Validation 4.0, transforms the way validation is traditionally performed. Applying Validation 4.0 (Validation by Design) will require adopting a new way of thinking and working, as the system requirements should be verified during its 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.
The Validation activities should take place through the process design and product development that establishes 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 called 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 Stage 2, System knowledge and understanding, coupled with a risk-based approach, are the keys to determining if the system performs as expected:
- Data Flow and Data Integrity
- System knowledge and understanding
- Supplier Assessment Review
- Requirements Risk Assessment
- Access Control Strategy
- 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:
- Re-qualification Policy
- System intended use
- System Preventive Maintenance Program
- Periodic Review
To ensure that the products are 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 the following parts:
- Process Validation
- Cleaning Validation
- Method Validation
- Computer System Validation (CSV)/ Computer Software Assurance (CSA)
- Facility, Utilities, Systems & Equipment Validation
- Transportation Validation
