For computerized system we mean a documented verification and high degree of assurance that a specific computerized system performs according to its specifications and quality attributes. Or, A system does what it is expected to do, and this performance can be documented.
Validation = Testing + Documentation + Process
We provide computer system validation services for automated manufacturing practices used in pharmaceutical and Medical devices industries. Having good exposure in process/equipment automation gives us good expertise in validation of the PLC/SCADA/Software based control systems.
Having under taken several validation projects makes us proficient service provider to take care of regulatory requirements.
We use a Risk based approach for computer system validation. We have good expertise in computer system validation documentation and validation execution as we follow current GAMP 5 guidelines and Medical Devices ISO 13485.
Vedant Tech Services can help Life Sciences companies ensure compliance and reduce costs. Our validation consultant/team provides a service for GMP, GCP and GLP application used in Pharmaceutical, Medical Device Industries and Biopharmaceutical Industries. Our background in technology and compliance puts us in an advantageous position to meet our client's validation needs.
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