Validation

In the course of selling and supporting measurement systems, we are frequently asked about product and software validation. These questions are mostly driven by compliance to FDA requirements in a regulated environment. These requirements are summarized by the FDA as:

“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

The key idea here is the need to apply validation to a specific process: yours. This means that a “one size fits all” or “validation in a can” approach is not going to get the job done.

AIS has developed and successfully deployed a validation process that addresses the key requirements of QUALITY SYSTEMS for regulated industries. (e.g. CFR part 820 sections 70, 72 and 75).  In the process of implementing “Measurement Systems Validation”, we have provided our customers with templates for IQR (Installation Qualification Requirements), OQ (Operational Qualification), and PQ (Process Qualification) and competently trained their employees to lead the next validation activity on their own.

AIS’s unique validation process focuses on:

    • Meeting requirements while minimizing non-productive activity
    • Making processes better as a result of the validation process
    • Objective evidence
    • Risk management

Call us for a brief introduction to this approach, and we will be glad to provide our initial assessment to you.  Get ahead before others do!

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