"JETT is looking at some of the documentation, like design requirements, and developing templates based on cGMP that have a validation checklist, or something very similar," says Dave Whittenton, Rockwell Automation's business development manager, life science. "You can just pull down the template for a bottle capper, for example."
"We invest in keeping abreast of user groups working on validation standards, and working on processes for users and suppliers to interact, like the JETT Group," says Dave Schuh, VP of sales and marketing at MGS Machine. "End users and suppliers can together hash through specifics of how to interact and develop a process flow that improves efficiency in improving equipment."
"We see a lot of user requirement specifications, and the current trend is to re-evaluate how to write a User Requirement Specification and how we can improve the URS documentation," says Whittenton. "The entire industry needs to get better at writing those, to get better at writing URS's that drive the functional specifications, and to get better on the front end so the back end is just check-box qualifications."
--By Brian Pelletier, Contributing Editor
"We invest in keeping abreast of user groups working on validation standards, and working on processes for users and suppliers to interact, like the JETT Group," says Dave Schuh, VP of sales and marketing at MGS Machine. "End users and suppliers can together hash through specifics of how to interact and develop a process flow that improves efficiency in improving equipment."
"We see a lot of user requirement specifications, and the current trend is to re-evaluate how to write a User Requirement Specification and how we can improve the URS documentation," says Whittenton. "The entire industry needs to get better at writing those, to get better at writing URS's that drive the functional specifications, and to get better on the front end so the back end is just check-box qualifications."
--By Brian Pelletier, Contributing Editor
