"Variation breeds inventory" -Shigeo Shingo



Validation in any language is one of the most misunderstood and confusing quality system requirements facing medical device companies. Let us evaluate your existing validation program against regulatory requirements or create a program tailored specifically for your needs. Our validation experts can assist with validation planning, protocol development, test lab selection, sample size determination, data review, statistical analysis, report writing, and independent review.

We provide validation assistance in the following areas:


Process Validation

– Equipment qualification
– Installation qualification (IQ)
– Operational qualification (OQ)
– Performance qualification (PQ)
– Test Method Validation (TMV)


Software Validation

-Software requirements
-Test protocols
-Test cases
-21 CFR Part 11


Biocompatibility Testing

-ISO 10993


Cleaning Validation

-Removal of manufacturing materials
-Removal of bioburden
-Reprocessed devices


Packaging Validation

-Sterile Packaging (ISO 11607)
-Seal strength/burst testing
-Shelf life/aging


Shipping Validation

-Transit testing (ISTA)
-Cold chain

Commons questions | QA

How much validation is enough?

That depends on the process and the mix of products manufactured with the process. Some processes can be validated with an IQ, OQ and PQ, whereas others may require more testing and analysis.

How many samples are required?

This is driven by the risk level/criticality of the process being validated. If the process is creating critical features, then the sample size should increase accordingly.

Can we verify our outputs instead of validate?

The FDA and IMDRF guidance documents allow verification in lieu of validation when the output cannot be fully verified. Keep in mind however, that in the past, FDA has indicated that “full verification” means 100%. Sometimes full verification is not a cost effective method, so validation is the best approach.

What is an acceptable indicator to demonstrate a process is validated?

A process validation is a capability study to demonstrate the ability of the process repeatedly produce product within specification. The study needs to include appropriate sample sizes and statistical methods to analyze the results.

When in the development of our process does validation need to be conducted?

The expectation is that validation activities are conducted prospectively, prior to commercial shipments.

Contact us today, to schedule a complimentary consultation.