Design Validation

Design validation step is used to prove that the design can meet the requirements set out
for it.

Once we decide what representative product (prototype) you will build to prove the design, you fully
test it to make sure that the product, as designed, will meet all the necessary requirements defined
in the Design Inputs.

Design Validation Report

The Design Validation Report describes the results of executing a Protocol and these results are
summarized as either PASS or FAIL. Design Validation Results that do not conform to the
Requirement(s) are listed and described in detail in the NON-CONFORMANCE FINDINGS section of
the Report (Section II).Non-conformances shall be investigated by the Project Lead (PL)/ Design Head
(DH) until the root cause of the non-conformance is determined. Where appropriate, as part of the
analysis, the non-conformance shall be duplicated (ability to induce the non-conformance provides a
degree of assurance that the root cause was identified).Investigation shall take into consideration
examples of common failure types such as:

Use of inappropriate test/ evaluation methods for the parameter or function being
evaluated
Use of test equipment or tools that are not in calibration
Human error, including failure to conduct testing according to the requirements specified in
the Protocol or in a referenced SOP, Standard, etc.

Non-conformance Findings may be resolved by design modifications, changes to Requirements or, if

appropriate, modifications to test or inspection equipment or methods. Design modifications will
require Verification and may require a new Validation Protocol and Regression Testing.
Requirements changes are processed using the appropriate Design Change SOP. Modifications to test
or inspection equipment or methods necessitate a repeat of the test using an approved revised
Protocol while resolutions must be conducted in a timely manner.

Acceptance of deviations and unresolved Non-conformances

Unresolved Non-conformances that do not affect safety or efficacy may be accepted with approval
of the PL / DH, Quality Assurance, and the CEO/ Design Review Committee (DRC). A detailed
explanation of the reason for acceptance must be entered in the Design Validation Report. When
Non-conformances are accepted, the Risk Analysis must be reviewed and updated as necessary.

Approval and Design Review

Quality Assurance finally approves the Validation report. The PL / DH schedules a DRC meeting in
accordance with the Design Review SOP to review the results of the Design Validation activities. The
PL / DH, Quality Assurance, and DRC approve the Design Validation by signing the Design Validation
Matrix.

All documentation is filed in the DHF (Design History File) by Quality Assurance / Document
Coordinator.
Depending on customer requirements validation can be recorded as a standalone document, or an
addition to the Statement of Compliance created in the verification step and looks as following