Company: Cardinal Health Inc.
Date: 7/10/01
Product: Drug Products
Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. The current validation procedure uses only the values that result in within specification findings, aberrant high findings, and aberrant low findings [21 CFR 211.165(e)].
For example, SOP 644.00, QA/QC Spreadsheet Validation, is deficient in that only a small range of values are being used to challenge computerized spreadsheet mathematical calculations
Failure to use fully validated computer spreadsheets to calculate analytical results for in-process and finished product testing [21 CFR 211.165(e)]. For example, the computer spreadsheets used to calculate analytical results for _____ have not been validated.
Failure to have appropriate controls over computerized laboratory systems to assure that changes in or deletions of records are instituted only by authorized personnel [21 CFR 211.165(e)].
For example, instrumentation where data is stored on the interfacing computer hard drive up to thirty days prior to being written on a compact disk for storage is available to all analysts. While the data exists on the hard drives, any analyst can access, print, or delete the data.
Regarding the validation of computerized spreadsheets used for in process and finished product analytical calculations (FDA-483, #4), your response states that current spreadsheets were challenged using the proposed revisions to SOP 644, QA/QC Computer Spreadsheet Validation.
However, your response does not indicate if computerized spreadsheets for all products which use the spreadsheets, were challenged using the proposed revisions to SOP 644. Also, your response does not indicate the reason why SOP-644 will not be revised until July 20, 2001, or the measures that your firm will take regarding in process and finished product calculations in the interim.
Regarding the failure to use fully validated computer spreadsheets to calculate analytical results for in process and finished product testing (FDA-483, item #5), your response states that old spreadsheets will be revalidated according to the proposed revisions to SOP 644 prior to being implemented into use. You identify that SOP 644 will not be revised until July 20, 2001.
FDA District: Cincinnati
