![]() ![]() SAS does not have a single database with an official record it uses individual datasets and does not have controls to ensure that the user is working with the right data. There are no workflows, electronic signatures, and even the use of “electronic records” is a bit off. Even custom coded software has a defined purpose and a list of requirements that can be tested.Ĭategory 4 does not seem right either, because SAS does not seem to be configurable in the way a pharmacovigilance system is. Emerson is responsible for developing, testing, and evolving the product. So the question becomes, how to categorize it? The temptation may be to put it into category 5, custom or bespoke software, but I think most would agree that that is not correct. Our GAMP ® 5 engineering approach is already helping life science customers to simplify compliance. GAMP calls this Category 3, or Non-Configured software2. You cannot test every reasonable permutation. There are five key concepts to GAMP 5: Product and Process Understanding Lifecycle approach within QMS Scalable Lifecycle Activities Science Based Quality. In a development platform, it is up to the developer to ensure that the program works. These controls can be tested and results can be verified. Both are Category 3 software types often called plug-and-play, this type of software is designed to be used. For the type of software we are going to refer to as Off-the-Shelf software, GAMP 4 called it Standard and GAMP 5 renamed it Non-configured. The overall approach, framework, and key concepts remain unchanged from the first edition. Note that the nomenclature changed slightly between GAMP 4 and GAMP 5. This is because I think of SAS as a development platform, rather than a software suite users can create SAS programs that can do almost anything.įor example, a pharmacovigilance system may have controls to ensure that users don’t do something like creating a record for a patient who is a 130-year-old man who is pregnant and weighs 180 mg. GAMP ® 5 Guide, 2nd Edition, aims to continue to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality. GAMP 5 Category 1: Infrastructure Software (includes operating systems, database. I have done a fair number of Commercial, Off-the-Shelf validations (GAMP 5 Category 4, Configured Software), and SAS is unlike anything I have done so far. three software categories as follows: Category 3: Nonconfigured Products. I am involved in the implementation and validation of a SAS Server environment, and I am conflicted about the best approach. If you select a Category 3 system, no more specifications are needed and development of test documents can begin (Step 7).
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