Do you have trouble finding a suitable CSV resource?
With the EasyGAMP approach you don’t need a person with CSV background. You may even employ a colleague changing jobs or reintegrating.
EasyGAMP is a lean Computer System Validation (CSV) approach for the Pharmaceutical and Medical Device industry, designed by IT experts themselves to match current IT and Agile practices. Compared to traditional methods, it is easy to use, reduces more than half of the validation effort, time, costs and paper! Nevertheless it is proven to be fully compliant with all regulations and even improves the actual quality.
For an explanation of all 8 benefits, goto Free Article
The benefits are established by:
- Have all regulatory requirements embedded into a set of templates for every possible validation document. This approach requires minimal training and support, so the user can focus on the content.
- Limit procedures to describe Who does What and When, while the How is defined in the templates. This prevents redundancy and discussion about the interpretation.
- Let the test results and issues be documented easily, so it doesn’t block solving issues and improving the quality of the computer system.
You may have the following questions:
Q: Do templates restrict the support of different systems and organizations?
The templates are risk based and parameterized to fit most of the computer systems. The responsibilities are defined via generic roles and can be mapped to any organization. Due to globalization most companies switch to standard solutions. And in case you have something unique, it is more efficient to use an approved standard approach for most of the work and justify only the exceptions.
Q: Does easy recording lead to incomplete or incorrect documentation?
In practice the opposite is true. Traditionally test results need to be recorded with pen on an approved print of the test plan. For every test or plan issue the run document needs to be failed and a deviation plan and report has to be created and approved. To prevent this burden, most issues are solved during dry runs and not documented at all. But IT experts are very dedicated to solve issues and willing to document when easy.
To experience the benefits, goto Free Validation Plan