SMB Validation

For an HPLC system, are the parameters entered for a chromatographic run considered an electronic record?

For an analytical instrument, any information that is captured by a computerized workstation is considered either data or metadata. (Metadata is described as data-about-data. It's what puts the real data into logical context.) The second that any information hits the 'durable media' it then becomes an electronic record. Parameters that are typically captured by an HPLC system (i.e. flow rate, sample lot #, etc.) are considered metadata. This information should be saved and protected as part of the official electronic record.