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Integrate typed validated

our agenda for today I wish to start off with giving some background validation information for people not experienced with validation and then we'll cover a few tools and techniques regarding validation then we will follow up with interface the various interface types that I have put down and the risks that are involved with those types of interfaces and then we will end up with our question and answer period so to start off with when we talk about the interfaces we're going to look at the three basic classifications that I have listed here we're going to look at the instrument level that is simple things like balances and pH meters as well as more sophisticated instruments like GCS and ICP IRS and other types of instrumentation in addition to look at interfaces between limbs and various types of software such as your chromatographic data systems your corrective and preventive action systems things like s AP MF g Pro your your very base at your various ERP systems you can also lump in there your human resource and other things like ELN s DMS and other types of software packages and lastly we'll look at interfacing other types of hardware such as your PDAs and tablets as well as online analyzers and and special remote devices I want to start off with by putting in a definition of what is validation and this definition comes from FDA guidelines and the purpose of a validation process is to provide that high degree of assurance that your computer system or other process will consistently produce a product which meets predetermined specifications and quality attributes basically what this means is that you're able to reap reduce the input and output that you get every step in that process and the activities within those steps do require that you form some documented evidence that you have completed these steps without that documentation the FDA and other regulated agencies do not consider the system to be validated the steps in your process and any associated activities you perform can and are run in parallel with the system development lifecycle and in most cases they will reference the various development documentation as you produce it so there are ties between the validation steps that you run the activities that you run and the int documentation that you produce beforehand the other part that I want to talk about a little bit is what's called risk based validation validation has changed over the years and current GAMP guide that is the good automated manufacturing processes guide now recommends risk based assessments as a way to approach your validations in this type of methodology the task you have is to identify the risks that are involved in your system and to classify them according to their importance in the simplest format you would consider a risk to be low medium or high depending on how that particular item impacts your product so in your risk assessment...