Validation Edge
Validation Edge, LLC is dedicated to providing leading-edge validation and related services to clients in the life sciences industry, ensuring regulatory compliance and cost competitiveness. They focus on the health and safety of patients and have extensive experience supporting pharmaceutical, biotechnology, medical device, diagnostic, and active pharmaceutical ingredient industries. Their services include process validation, cleaning validation, computer system validation, analytical method validation, and more, with a strong emphasis on scientific, compliant, and cost-effective solutions.
Industries
Nr. of Employees
small (1-50)
Validation Edge
Lenexa, Kansas, United States, North America
Services
Creation of validation policies, master plans and SOPs to structure validation activities across facility, equipment, process and computerized systems.
Preparation and execution of commissioning and qualification protocols and final reports for facilities, utilities and equipment, including URS/FRS and acceptance testing support.
Development of process validation protocols based on process design, identification of CQAs/CPPs, statistical analysis, and continued verification to ensure reproducible commercial manufacturing.
Design and implementation of cleaning programs, residue recovery studies, validated sampling plans and remedial actions to prevent cross-contamination.
Preparation of analytical SOPs, validation and transfer protocols, laboratory equipment qualification and stability study support, plus data integrity and gap analyses.
Validation of computerized systems used in regulated environments to ensure compliant performance and documentation.
Creation of validation policies, master plans and SOPs to structure validation activities across facility, equipment, process and computerized systems.
Preparation and execution of commissioning and qualification protocols and final reports for facilities, utilities and equipment, including URS/FRS and acceptance testing support.
Development of process validation protocols based on process design, identification of CQAs/CPPs, statistical analysis, and continued verification to ensure reproducible commercial manufacturing.
Design and implementation of cleaning programs, residue recovery studies, validated sampling plans and remedial actions to prevent cross-contamination.
Preparation of analytical SOPs, validation and transfer protocols, laboratory equipment qualification and stability study support, plus data integrity and gap analyses.
Validation of computerized systems used in regulated environments to ensure compliant performance and documentation.
Expertise Areas
- Process validation and lifecycle implementation
- Cleaning validation and contamination control
- Analytical method validation and laboratory qualification
- Commissioning and equipment qualification (IQ/OQ/PQ)
Key Technologies
- Quality by Design (QbD)
- Lifecycle process validation (Stage 1–3)
- Cleaning validation and surface swab sampling
- Analytical method validation and method transfer
News & Updates
Are Your Validation Efforts Based on Sound Process Design?
Process design is the key to effective validation, emphasizing the importance of understanding, detection, impact assessment, and control of process variations.
The Four Pillars of Validation
An article explaining the four fundamental principles of validation.
Peer Reviewed: Cleaning Validation
Application of the lifecycle approach to cleaning validation to develop compliant, effective, and efficient cleaning programs.
Leveraging Change for Continuous Process Improvement
Managing change and overcoming employee resistance through proactive approaches.
Implementing cleaning validation requires process understanding
Focuses on the importance of understanding the cleaning process to develop effective validation programs.
Effective Problem Solving - The Real Key to Success
Highlights the importance of problem solving in quality improvement programs.
Are Your Validation Efforts Based on Sound Process Design?
Process design is the key to effective validation, emphasizing the importance of understanding, detection, impact assessment, and control of process variations.
The Four Pillars of Validation
An article explaining the four fundamental principles of validation.
Peer Reviewed: Cleaning Validation
Application of the lifecycle approach to cleaning validation to develop compliant, effective, and efficient cleaning programs.
Leveraging Change for Continuous Process Improvement
Managing change and overcoming employee resistance through proactive approaches.
Implementing cleaning validation requires process understanding
Focuses on the importance of understanding the cleaning process to develop effective validation programs.
Effective Problem Solving - The Real Key to Success
Highlights the importance of problem solving in quality improvement programs.