Free download us-fda guidlines

Firstly we discussed the Laboratory Information Bulletin. This outlines what the FDA expect to see when you validate a multi user spreadsheet i. It is an internal FDA procedure. You can download it here. We also discussed the Laboratory Information Bulletin of what the FDA expect to see when you use a single user spreadsheet. This method of spreadsheet use is not however very common in regulated industries. Again, this is an internal FDA procedure.

Within the documents spreadsheetvalidation. If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman. Some Web links URLs embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA. Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time see 21 CFR Comments are submitted electronically through regulations.

For more information, see:. Margaret A. Commenting on Guidance Documents. For more information, see: How to Use Regulations.