Process Validation
Does your process consistently produce a result meeting predetermined specifications?
Does your process validation have the right stuff?
Global Harmonization Task Force (GHTF) Process Validation Guidance
Process validation isn't just about meeting regulations and standards ...
It's about giving your business a competitive advantage ...
It's peace of mind ... that your products are of the highest quality.

Can you provide objective evidence that answers the following questions?
If you can't, contact us today, to assess your process validation needs!

Design Validation:
Do your device specifications conform to user needs and intended uses?

STAGE III:
Performance Qualification Can you demonstrate, with a high degree of assurance, that your process consistently produces a result that meets predetermined requirements?

STAGE II:
Operational Qualification

Do your tools, equipment, systems, and people work together as a system, and are they capable of consistently meeting
process requirements? Have you established process control limits and action levels which result in product that meets all predetermined requirements?

STAGE I:
Installation Qualification

Did you order the right equipment and ancillary system for your process?
Did you receive exactly what you ordered?
Was it properly installed per manufacturer's approved specification?
Did you consider supplier recommendations?
Do your facilities adequately and reliably provide the utilities and environment the process requires?



New addition!

Happy New Year 2016!
Best wishes.




Home

Contact Us

QMS

Consultants


The Atzari Way:

- Born Lean

- Quality by Design

- Robust Process Performance
















 
 
Process Excellence for the Life Sciences