Prodiqua

As the digital environment and the information technologies are not your expertise, PRODIQUA advices you on the definition of digital transformation strategy and the deployment of digital solutions in compliance with the applicable regulatory requirements. We lead digital projects based on the fundamentals of quality assurance et a risk-based approach. We ensure that all required means and actions are deployed in order to meet the regulatory requirements of pharmaceutical and DM industries, during all project phases, upstream to Go Live. Our Area of activities UPSTREAM PHASE - Assess the framework of digital transformation for the quality area and identify the key performance levers - Build a digital transformation strategy tailored to the needs of the company - Define the digital transformation program on the quality area (scope, ROI, management)- Manage the supplier/solution selection process (URS writing, risk identification) DEPLOYMENT PHASE - Structure and plan deployment activities (priorities, setting up of pilot sites, integration strategy) and determine responsibilities:~ System Setup ~ Validation strategy and validation plan ~ Test phase (UAT, challenge tests)~ Communication and support plan for changes ~ Training plan ~ Remediation of existing QMS (SOPs)- Manage activities with the transversal stakeholders and resolve roadblocks - Provide technical expertise to the quality team in the implementation of this transformation PRODUCTION Phase - Monitoring activities and implementation of periodic reviews PRODIQUA turns green! We are also able to assist you on your sustainable transformation projets in the framework of the new CSRD implementation.