Computer System Validation in ISO 9001, GDP Pharmaceuticals, Cosmetics, etc

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It is very common for companies to wonder what use a computer validation has, as has never been done, and even if you have a Quality System. Quality Systems today are computer -based, and not just for the documentation or access to records, but for the actual management of records, using methods and proper storage and operational business intelligence, some web support, cloud, etc. However, despite the importance , usually only keep monitoring and internal or external computer maintenance company, sometimes without delving into the suitability of the system itself, software, skills, etc. . Computer Validation is an evaluation of the system as a whole and in a complete overhaul of the design and adaptability to the company and the future, that enables to monitor its needs of change, evolution, and modification of any kind. There are different methodologies or analysis systems, perhaps the best known is GAMP, but there are others in which the approach can be a priori ( before selecting the system), or afterwards (once you have the system installed). In our experience, any company that performs the validation of its information system, always finds improvement opportunities, performance, security, etc, and is very pleased cause definitely adds value.

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