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Support Services Outsourcing
Where the GvP (for the EU) and specific legislation in other territories refers to “the quality processes”, they are referring to Standard Operating Procedures (SOPs). These fit into the overall information structure of the company like this: SOPs are the quality control documents which implement company policy. Working practice documents are then derived from the SOPs to provide detailed guidance to staff in the execution of the tasks outlined in the SOPs. For those working within a pharmacovigilance system, training on SOPS would also be expected as well.
Auditing is an essential component of any pharmaceutical company’s Quality Management System. If carried out correctly, auditing provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations.
What Is a CAPA And Why Is It Required? Corrective And Preventative Actions (CAPA), also sometimes termed Corrective Action Plans (CAPs), are compiled from the findings of inspections and audits. Inspections are carried out by regulatory authorities, audits can be carried out internally or they can be conducted by an external party.
Why Invest in outsourced Training ? Quality training is ultimately a compliance issue. The current guidelines on Good Pharmacovigilance Practice clearly emphasise the link between meeting regulatory quality standards and having adequately trained personnel1. Modern drug safety practice relies on professionals who are fully versed in all the relevant processes and regular communication between those professionals and relevant third parties such as regulatory authorities
WE OFFER EXPERT AND COMPREHENSIVE MEDICAL CONSULTANCY SERVICES PrimeVigilance offers Medical Consultancy services providing companies medical support by a physician group experienced in all areas of Clinical Safety, Post Marketing and Medical Information lead by Dr. Cvijeta Bielen.