Verification and Validation

Validations are conducted in accordance with FDA and ISO 13485 regulations.

New Health Sciences takes pride in ensuring proper Equipment Installation, Qualification and Validation.  It also ensures that the process established is robust for the product and is well captured by considering setup parameter windows. 

Services include:

• Process failure mode and effects analysis (pFMEA)
• Installation qualification
• Operational qualification
• Process performance qualification
• Seeded failures for inspection qualifications
• Lot qualifications
• In process test design
• Process control charts