Basic principles CSV and CSA

Purpose

Process systems, laboratory equipment & systems, ERP systems, quality systems, etc. that are controlled or supported by a computer system must comply with a number of strict rules with regard to continuity, reliability and data integrity. With Computer System Validation (CSV), manufacturers of pharmaceutical products provide documented proof that an automated system will perform consistently and comply with the prescribed regulations. As an integral part of the System Development Life Cycle (SDLC), to avoid the risk of finding discrepancies between regulation and operational practice at a later stage). The validation process provides documented evidence that the system meets specifications throughout its lifecycle. However, the approach is currently under discussion at the FDA, among others. The new draft guideline on Computer Software Assurance for production, operations and quality system software has emphasized "critical thinking" as a critical component during the implementation of automated systems. In short, it is a paradigm shift from document-oriented computer system validation practices to critical thinking practices. Industry and the FDA are driving the shift to computer software assurance (CSA).

Traditionally, the FDA's Computer System Validation (CSV) focuses on documentation, followed by testing activities, assurance needs, and critical thinking. While in the new CSA model it focuses first on critical thinking and then Assurance needs, testing activities and documentation.

Target Audience

Employees of organizations that are directly or indirectly involved with ICT systems and are operational in conditioned environments that fall under quality regulations and controls. If these systems have a direct relationship with data that can determine the approval of a product, they must be qualified according to these guidelines.

Intent

This training consists of 3 days and covers the differences between CSV and CSA, the approach, drawing up Risk Analysis, Protocol and implementation.

Program

·        Introduction Computer System Validatie (CSV) and Computer Software Assurance (CSA)

·        What does GMP regulation say about this (USA FDA 21 CFR, Part 210, 211 en 11, Volume 4 Annex 11, EU GMP and  GAMP5©)

·        Determining whether a system is subject to validation

·        How do you determine the measurement values

·        Write protocol

·        Determining the frequency of execution of measurements

·        Calculate and document results

Qty participants   8 - 12