|
Product & Process Validation |
Ontex offers a wide range of independent validation and verification services to help you meet that challenge of complying with U.S.A., Europe, Japan requirements and directives.
Whether it's device design validation, software validation or manufacturing process validation, we ensure that your product meets domestic and international quality standards.
We follow a documented, comprehensive, systematic examination to evaluate the adequacy of the design requirements. Additionally, we examine its potential ability to reach those requirements, to anticipate possible problems, and to offer proactive solutions.
- Risk Assessment and Management
- Product Design Verification
- Process Capability Analysis
- Equipment Installation and
- Operations Qualifications
- Process Performance Qualification
As an ISO 9001:2000 certified manufacturer, we adhere to the rigorous quality standards and test procedures necessary to ensure compliance with your performance specifications.
|
