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Showing results for tags '21 cfr part 11'.
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Freelance/consultancy help needed at our Southern California location. I have a project where I need to take an existing LabVIEW solution and adapt it to make the application FDA 21 CFR Part 11 compliant. The application is a machine vision solution using the Vision Development Module. The vision part is working well and doesn't need to be replaced. The system uses machine vision to inspect pharmaceutical injection components. I'm looking for an engineer with experience in developing, qualifying and validating Part 11-compliant systems, including the addition of audit trail and data integrity functionality. I wrote all of the original LabVIEW code so you would be working directly with me to implement the solution. I work at Amgen, a large biotechnology/pharmaceutical company based just north of Los Angeles. I have a preference to work with engineers located within reasonable driving range of our facility, however due to the niche nature of this project we can probably be somewhat flexible with distance. If you are interested please contact me and I will call you to discuss the project in more depth.