This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.
CSV is an important part of the development and use of computer systems within clinical trials and it applies not just to specialist e System vendors, but also Clinical Trials Units (CTUs) or Clinical Research Organisations (CROs) offering randomisation and Interactive Response Technology services, specialist analytical software developers and sponsor organisations developing their own software solutions.
This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and changing. A written detailed description of the system should be produced (including diagrams as appropriate) and kept up to date.
It should describe the principles, objectives, security measures and scope of the system and the main features of the way in which the computer is used and how it interacts with other systems and procedures. The software is a critical component of a computerised system.
In this case the starting point was their latest major upgrade, essentially a new build to bring the product up to date with the latest programming technology that had been released into production for their customers.
I’m not going to go through the whole product development life cycle and I appreciate with new Agile and Sprint development methodology processes are changing, but at some point you will have a finalised specification document.
If a manual system is being replaced, the two should be run in parallel for a time, as part of this testing and validation. Data should only be entered or amended by persons authorised to do so.Efficacy and safety of products are the final goals of such developments.Therefore, Merck/Merck Serono implemented an additional specifically developed quality management system that covers all areas and locations in Merck Serono Research that were not yet regulated by an existing regulatory quality management system, e.g. The system is known under the name Merck Serono Research-Quality Management System (MSR-QMS).Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company.Furthermore, the implementation process in one specific research department will be highlighted.
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Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities.