Validation Reports
Various reports may be required during the overall completion of the validation exercise. These are usually produced at significant milestones in the overall validation exercise and they will have been defined in the validation plan. These reports will, for example, record progress made, results from the qualification activities performed, scope changes, deviations, training and system maintenance procedures. Reports may cover specific activities or cover activities to date i.e. interim reports, or be the final report from the overall exercise.
The following are examples of the reports that Industrial Technology Systems (ITS) has experience in producing:
- Audit Reports
- Design Review Reports
- Code Review Reports
- Development Test Reports
- Installation Qualification Reports
- Operational Qualification Reports
- Performance Qualification Reports
- Interim Validation Reports
- Final Validation Reports
With a quality management system developed around GAMP®, ITS’ engineers can apply their knowledge and understanding of the validation lifecycle model, validation phases and the intricacies of project design, execution, and testing, to produce high quality, accurate documentation and reports that will satisfy regulatory authorities.
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