We provide chamber validation solutions to FDA/ICH regulated industry.  To designers, owners, and installers of Controlled Environmental Chambers (CEC).  Our value added service provides a level of confidence that final product or sample storage or processing of an intermediate is exactly what is required and operationally needed.  In addition, we support the life science research through quality standards and preparing them for collaboration by establishing the framework for a proof of principle (POP).    

Design Qualification:

          Specifications should contain …

          Expectations are to be met and verified by … 

Validation

          Expectation verification is different from validation by …

A chamber will be validated to FDA/ICH standards by …

Performance Based Design

          Performance drives future designs by …

          We can be learn from performance …

Quality Standards in Basic Biomedical Research

          Proof of principle requires …

          WHO guidelines dictate … as bare essentials

          Contact a company for collaboration when …

"To control the product one has to control the people involved in making the product, which simply means a clear and concise communication of expectations, deliverables and outcomes.  We fill in the gaps and bring together representatives of their respective fields.  “ Mr. Lemetti