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hello my name is Christophe ledger notes I'm a senior validation and compliance analyst with montréal thank you all for taking the time to join this webinar today I will be covering strategies that can be employed when validating a computerized GXP system in particular we'll be focusing on the documentation generated as part of the validation effort since these documents are likely to be reviewed during regulatory inspections so I'll just start with giving me some background about myself I have degree in chemical engineering from McGill University and 13 years of experience in the pharmaceutical industry I have a sense of experience and validation including the validation of equipment of prepend facilities in addition to computer system validation which is a subject for this course I also have experience in QA functions related to complete management and the approval of controlled documents and I've also worked in engineering functions tied to equipment selection and purchasing and investigation reporting for the past two years I've been working from Ontario Montreal one trium is a technology company focused on the delivery of enterprise content management solutions and professional services for the life sciences industry our platform on tree and connect consists of solutions for electronic trial master files document regulatory document management submission planning and quality management for services and validation Quality Assurance auditing and strategy my team was founded in 2005 and is headquartered in Montreal but we work with companies around the world including in North America Europe and Asia here's a brief overview of today's presentation I will start off by reviewing some key concepts related computer system validation next I will cover how to prepare for testing including tips for planning the validation activities for writing test scripts and for choosing evaluation team I will also talk about the execution of test scripts with a focus on good documentation practices on generating screen captures and on how to properly document non-conformance --is after that we'll discuss traceability and reporting and finally I'll conclude the presentation with some recommendations for undertaking a computer system validation project so let's start out with some basic terminology that comes up a lot in computer system validation starting with GFC systems so what exactly is a GXP system the term to expiry to a set of compliance regulations and a GXP system is a computerized system performing activities that are subject to these regulations some examples of computerized systems use for GXP activities so any systems used to generate electronic records and this could be pretty much any sort of quality documentation that your organization chooses to manage electronically so things like training records complaint files change requests incident reports another example would be systems used to store or manage data that a subject regulations so such so a system used for adverse event reporting or used to store raw data obtained during laboratory or production activities so we've established a GXT systems generate electronic records the FDA defines an electronic...