Business Case and Issues

In regulated environments such as GMP, GCP or GLP, validation is a must. But also in none regulative environments relying on business critical computerized systems, validation can be a key step to reduce the risk of system failures, and consequent business implications.

Validation is a methodology to develop a system and provide documented evidence that it performs according to the predefined requirements. The key is finding the balance between the validation efforts, and the risk a computerized system imposes on a company. IBR AG focuses on the planning, implementation and application of validation methodologies on a project or company level.