pharmaceutical validation: VALIDATION DURING SOFTWARE DEVELOPMENT

Validation of softwares during development is performed in three distinct stages:

1. Validation of Design Inputs

2. Validation of the Implementation stage

3. Validation of Alpha and Beta Testing

1.0 VALIDATION OF DESIGN INPUTS

1.1 Design Specifications

Prepared By : ________________

Approved By : ________________

Design Checked By : ________________

1.2 Validation Report

This shall include

a. Internal Design Document.

b. Report on Design Inspection in above format.

c. Comments e.g. whether Design Specifications are complete, correct, and consistent with the defined requirements.

2.0 VALIDATION OF IMPLEMENTATION PHASE

2.1 Validation Report

This shall include

a. Description on Source Code and Internal Documents used.

b. Report on Functionability and reliability of individual and group programming.

3.0 ALPHA TESTING

3.1 Inputs

3.1.1 Test cases Prepared By : QA Person.

3.1.2 No. of Test Persons : 10 - 20

3.1.3 Type of the information

provided to the Persons : Detailed Test Description and Expected Results.

3.2 ALPHA TEST SUMMARY SHEET

The test results are evaluated Graphically. The defect Discovery Rate plotted versus the Total number of Defects Discovered. A regression linear fit curve is calculated and plotted together with maximum and minimum fits, which by definition have a confidence interval of 5%. This helps in calculation the number of remaining defects. This information is useful to forecast the number test cycles that are still necessary and a possible release date.

The number of critical defects after the last test cycle must be zero for the software to pass the release criteria.

4.0 Beta (b) Testing

Once software defects and usability discrepancies reported during alpha testing have been corrected, the software may be tested at selected customers’ sites (the so-called b- test). The key feature of b-testing is that it is conducted in a customer environment and supervised by a person not involved in the development process. One of the objectives of b -testing is to test the HP Product delivery and support channel. A trained HP applications engineer (AE) assists the customer with installation and checks the software installation procedure.

4.1 Validation Report include:

Test plans with acceptance criteria and test cases

Test results

Validation documents

Defects density report.

User Training Material

System status bulletin (SSB)