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Description

Global authorities require that all GXP relevant computer systems (LIMS, ERP, Laboratory Device Software, production Software, etc.) must be validated in a documented process known as computer system validation (CSV) based on EU GMP Guideline Annex and FDA CRF 21 part 11. The requirements for planning, documenting, and undertaking CSV can be costly in time, money and personnel resources. Zamann Pharma Support is a specialist in GAMP5 based Computer Systems Validation and provides CSV services for: - Gap assessments - Implementation and transfer plans - Global project management - Entire validation activities - Test planning and test execution - Establishment of corporate CSV procedures - Global key user management - CSV based test automation (new innovative product) Zamann Pharma Support is also innovating the future of CSV through Continuous Validation and automated test execution: We are pioneering Continuous Validation and we are able to create huge advantages and benefits for companies who are focusing on continuous digitalisation and automation. Continuous validation will strongly improve compliance and provide quality reporting and KPI systems which where not possible before.

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