6 Validation

Tools to be used for analysis work in highly regulated environments, such as the pharma industry, require validation. Such a validation in principle needs to be conducted by each individual organization who wishes to use a specific tool. Some companies make shortcuts by stating:

If it is on CRAN then it is automatically validated.

That this is certainly not a viable approach for ensuring compliance to health authority requirements (or simply for even basic reproducibility of results) should be obvious by now. If not, see the CRAN Nightmare section.

What we at IntiQuan do ensure is that our IQR Tools R package is fully validatable.

6.1 Validation of IQR Tools

The validation of IQR Tools at IntiQuan is conducted in a systematic manner, using a risk-based approach, summarized in seven main documents:

1. High Level Risk Assessment
2. System Description, User Requirements and Risks
3. Validation Plan / Test Plan
4. Installation Qualification Specifications and Results
5. Performance Qualification Specifications and Results
6. Validation Report / Test Report
7. Change Management

A full test-suite has been developed that by execution tests the following aspects of IQR Tools:

• Correctness of the installation (IQ)
• Correct working of the included functions (OQ)
• Adequate coverage of the users requirements (PQ)

If no error and no warning is returned by this test-suite, the tested version of IQR Tools is considered validated on the IntiQuan system.

6.2 Validation support

On request, IntiQuan offers validation support of IQR Tools to organizations. Please contact info@intiquan.com.