RCM has skilled consultants to support and train your teams on Quality Assurance (QA) and Quality Control (QC).
RCM has been providing compliance services to our clients for over two decades and understands that QA (verification preventative activities) and QC (validation and corrective action preventative action (CAPA) processes that are intended to fix defects)) are essential in delivering the highest quality processes and software products.
Quality has two roles: provide assurance that your processes are compliant with the regulation; and ensuring that you have controls in place to identify and fix defects with the required corrective actions to produce quality products. Your policies, standard operating procedures (SOP) such as your, Software Development Lifecycle (SDLC), need to identify required regulations for compliancy with FDA, EU, and ISO 9000 standards and more.
RCM has the capabilities to implement your Quality Management System (QMS) system, your Learning Management System , your eTMF (electronic Trial Master File), your Clinical Sample Management System and other quality systems. RCM can develop your Quality policies and SOP; perform pre- and post- quality audits; facilitate mock inspections; develop quality processes; harmonize your SOPs both local and global.