Job at a glance
Client have developed or use a number of tools (in house and some external) to validate software I/O to their system. These tools need to be validated and the validation protocols need to be documented. It would be a great if candidates have exposure to or familiarity with FDA/regulatory validation process. Tasks & skills: - some examples of such tools are: a tool that pulls information out of a log file and generates reports; a tool that interacts with their instrument system and simulates a run; a tool that generates simulated sample reports from a config file; MD5 stamping/validation etc.
- these resources would come in, learn what these tools do and then "reverser engineer" writing of test protocols, test cases and execute test procedures. - a plus (but not a must)- familiarity with test automation so that they can help the client team for the long term - some of these tools use SQL servers for data store Premarket Approval (PMA) validation · High level scope is writing a validation plan, high level user requirements for about 5-10 small tools (they would need to learn and understand the tools) · write some test procedures, execute the tests, and · write validation reports · Help in PMA submissions · Domain experience with 21 CFR.
814, 21 CFR. 820