Validation is one of the most important activities for an automation partner. The documentation serves as a framework for equipment design for all mechanical, electrical, and software components of the system and upon machine completion becomes a troubleshooting guide to address any issues that arise during the lifecycle of the equipment.
Utilizing the GAMP-5 Guide as a basis, Kahle provides custom validation documentation suited for each customer's individual requirements, following a "risk-based approach."
We offer a unique, easy-to-understand graphical approach to validation, designed to be read and understood by program managers, designers, mechanics, and operators alike. This documentation has proven to be an invaluable resource in assessing process and equipment risk during development using input from all customer departments.
Our validation team is flexible to utilize existing customer internal document templates and structure for ease of integration into existing document control or can deliver a validation package based on Kahle standards. Our Validation Services include development of:
- Quality Plan and / or Validation Plan
- Sequence MAP for all Equipment Processes and Functions
- Functional Requirements Specification
- Design Requirements Specification
- Factory Acceptance Test Protocols and Report
- Installation Qualification Protocols and Report
- Operational Qualification Protocols and Report
- Performance Qualification Protocols and Report
Through our validation process, we enable our customers to achieve and maintain Current Good Manufacturing Practice compliance with all relevant regulatory body requirements.
To assure the quality of every item that comes off the production line, Kahle performs a comprehensive risk analysis during multiple stages of the project to unearth uncontrolled conditions related to operator safety, machine safety, efficiency, product quality, data integrity, and product user safety. The aim is to reduce risk in the assembly and inspection processes to ensure robust and reliable equipment.