Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].
Your firm’s laboratory analysts have the ability to access and delete raw chromatographic data located on the [redacted] of [redacted] used to conduct HPLC testing. Due to this unrestrictive access, there is no assurance that laboratory records and raw data are accurate and valid.
Your firm’s laboratory analysts have the ability to access and modify the formulas in the Excel spreadsheets used to calculate assay results for Guaifenesin and [redacted] drug products. Due to this unrestricted access, there is no assurance that the formulas in the Excel spreadsheets are accurate and valid.