1. per my understanding, it should be owned by "project / program manager", and shall be defined in consultation with the key stakeholders ( viz., technical lead and regulatory etc); also certain references.,
https://alvintai.com/wp-content/uploads/2015/01/Design-Control-SOP.docx
2. as these documents are alive and evolve with the product development, there are two options
a. to revise and version them through the life cycle. ( with appropriate change management/controls from set stage viz., D.Input can be updated without change control till Design Verification Plan; but any changes later should be put through formal change control)
b. to update through addendums, and integrate the details at a set milestone viz., for D.Input, integrate before Design verification.
per my understanding, 2.a is right choice. as per FDA's guidance.
https://www.fda.gov/media/116573/download
pl guide with clarification and reference
https://alvintai.com/wp-content/uploads/2015/01/Design-Control-SOP.docx
2. as these documents are alive and evolve with the product development, there are two options
a. to revise and version them through the life cycle. ( with appropriate change management/controls from set stage viz., D.Input can be updated without change control till Design Verification Plan; but any changes later should be put through formal change control)
b. to update through addendums, and integrate the details at a set milestone viz., for D.Input, integrate before Design verification.
per my understanding, 2.a is right choice. as per FDA's guidance.
https://www.fda.gov/media/116573/download
Eventually, the design input must be reviewed for adequacy. After review and approval, the design input becomes a controlled document. All future changes will be subject to the change control procedures, as discussed in Section I (Design Changes)
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