Excel Spreadsheets


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  1. Warning Letter: Inadequate spreadsheet (ucm406826)

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    Also, your firm tracks complaint data on a spreadsheet that contains free form text fields that are not standardized, resulting in an inability to adequately trend the data. For example, when using complaint data from January 1, 2011 to February 19, 2014 to trend for “Description of Failure” for “6090,” fourteen complaints are shown. However, the spreadsheet contains several different descriptions of the same part failure that when totaled resulted in a total count of forty complaints related to the inline coupler, part #6090.”

    View the original warning letter.


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  2. Warning Letter: Uncontrolled Excel spreadsheets (ucm369409)

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    For example, your firm failed to have adequate procedures for the use of computerized systems used in the QC laboratory. At the time of the inspections, your QC laboratory personnel shared the same username and password for the operating systems and analytical software on each workstation in the QC laboratory. In addition, no computer lock mechanism had been configured to prevent unauthorized access to the operating system. The investigator noticed that the current QC computer users are able to delete data acquired. In addition, the investigator found that there is no audit trail or trace in the operating system to document deletions.

    Additionally, at the Aarti Drug Limited facility (FEI 3009688205), the investigator noticed that the use of the Excel® spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion. The investigator noticed that the calculation for residual solvent for [redacted] uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets.

    View the original warning letter.


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  3. 483 from BioQuality, Vol. 14(9): Use of Uncontrolled Excel Spreadsheet

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    Uncontrolled Excel spreadsheet is used for: • issuance of deviation numbers • tracking deviations to closure • trending deviation data This has resulted in: • CAPAs not always being linked to associated deviations • Deviation priority levels not always being consistent Validation of QC lab software failed to demonstrate adequate security: • Analysts have the ability to overwrite original data • No individual user names and passwords limiting access to the system “


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  4. Warning Letter: Lack of spreadsheet controls (UCM 311326)

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    Specific violations observed during the inspection include, but are not limited, to the following: Your firm has not established appropriate controls designed to assure that laboratory records include all data secured in the course of each test, including graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested [21 CFR 211.194 (a)(4)]. Specifically, the inspection revealed that your firm has not established written procedures to control and account for electronically generated worksheets used by analysts to record analytical test results. Analysts in your QC laboratory print an uncontrolled number of worksheets from computers throughout the QC laboratory without supervision.

    View the original warning letter.


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  5. Warning Letter: Failure to validate Excel Spreadsheet (ucm256498)

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    Failure to validate software used as part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(I). For example, your firm did not validate use of an Excel spreadsheet used to calculate the Moisture Vapor Transmission Rate (MVTR) per test procedure [redacted] Revision B.

    View the original warning letter.


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  6. Warning Letter: Spreadsheet data entry cells not locked (ucm229262)

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    We observed 8 of 9 worksheets where one or more tabs with formula cells were not locked. These worksheets were used for analyzing raw data from drug component and product samples, including [redacted]. Your firm’s SOP 100-G-0110, “Creation and Use of Templates,” stated that cells, in which data is entered, must be locked within their electronic template.

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  7. Warning Letter: No Procedures for Controlling Worksheets (ucm218221)

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    Your firm has no procedures for controlling laboratory worksheets including changes to worksheets, issuance of laboratory worksheets, and reconciliation of laboratory worksheets. The worksheet “Internal Communication – Batch Release Information” by the warehouse, which is used to identify released product, was created after [redacted] documented release of finished product for Heparin I.V. Flush Syringes and Normal Saline I.V. Flush Syringes prior to obtaining media fill results. This sheet is used to communicate batch release information to warehouse operations. Use of this sheet is not documented in any Medefil procedure nor is control over this sheet documented.

    View the original warning letter.


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  8. Warning Letter: Uncontrolled spreadsheets (ucm227896)

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    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.

    View the original warning letter.


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  9. Warning Letter: Failure to Validate Spreadsheets (ucm185865)

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    Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, when requested, no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs.

    View the original warning letter.


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  10. Warning Letter: Spreadsheet Calculations not Verified or Documented (ucm174100)

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    Your laboratory records did not include a record of all calculations performed in connection with laboratory tests as required by 21 CFR § 211.194(a)(5). For example, laboratory notebook #7, page 49, documents the assay results, but not the calculations performed in Test number DSFS D-13 and Test number TG 521 for the analysis of [redacted], lot #HI7908. The notebook does not document reference to the spreadsheet calculation used to generate the results. In addition, the assay results generated by the spreadsheet were not verified for accuracy. Your response dated February 16, 2009, states that you have established procedures to ensure that calculations of method validation studies are recorded. The Records Management SOP, Section 5.7.4.7, states that the procedures shall define what and how data is to be recorded in respective logbooks. However, this SOP omits instructions to include in the notebook the reference to the spreadsheet calculation used to generate the results, as well as the raw data and calculations. In addition, you continued to release products based on assay results generated by the spreadsheet that have not been verified for accuracy.

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