Software Validation


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  1. 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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  2. Warning Letter: Failure to Establish Validation Program (ucm366715)

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    "your firm failed to establish a
    validation program
    for the computer software Microsoft Dynamics used for production, inventory, lot number generation, and laboratory test methods used for raw material, bulk, and finished product test release.  Your firm also uses the Microsoft Dynamics program to assist your quality unit for product, document and component control.

    View the original warning letter.


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  3. Warning Letter: No CAPA Procedure (ucm 360143)

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    These violations include, but are not limited to, the following:

    Failure to establish and maintain adequate procedures for implementing corrective and preventive action and failure to document all activities under 21 CFR 820.100 and their results, as required by 21 CFR 820.100(a).

    For example: Your Quality System Manual, dated 10/09/2012, Rev. A, Section 8.4 states that your firm has established procedures to document and analyze quality data from complaints, internal audits, supplier performance and non-conforming materials. Section 8.5 states that your firm has implemented a corrective and preventive action (CAPA) program to eliminate the cause of nonconformities in order to prevent recurrence. However, your firm does not have any written CAPA procedures. In addition, you have no records of analyzing quality system data obtained through sources such as complaints, internal audits, supplier performance and non-conforming materials, to determine if a CAPA action is required.

    View the original warning letter.


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  4. Warning Letter: Medical device company failed to validate computer software (ucm 355751)

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    Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, your firm’s design verification procedure does not require that test equipment and software are fully validated, as needed, and prior to use in design verification activities.

    View the original warning letter.


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  5. Warning Letter: Missing Validation Testing (ucm 359625)

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    Your firm does not have a design history file (DHF) for the Meridian DR 200 single panel X-ray system. The system is comprised of a workstation, flat panel detectors, acquisition software and X-ray hardware. Missing elements of the DHF include:
    • A design plan for the project
    • Established or approved design inputs/outputs for the system
    • Verification or Validation testing for the system
    • Design Transfer
    • Risk Management for the system
    • Design Reviews.
    Your firm does not have procedures to describe the content of your Device History Records (DHR’s). In addition, eleven of eleven DHR files reviewed showed that all were incomplete as the only record in the files was your testing of the flat panel detectors, which is only one part of the X-ray system. The DHRs do not include installation records; records of any non-conformities; records regarding the X-ray hardware, workstation or acquisition software; or records of final product testing and quality release of your systems.

    View the original warning letter.


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  6. Warning Letter: Firm not reporting all electronic results obtained (ucm 361553)

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    We observed and documented practices during the inspection that kept some samples, data and results outside of the local systems for assessing quality. This raises serious concerns regarding the integrity and reliability of the data generated at your Kalyani plant. For example,

    a. Our review of the Chromeleon and Empower II software found that your firm was testing samples unofficially, and not reporting all results obtained. Specifically, “test,” “trial” and “demo” injections of intermediate and final API samples were performed, prior to performing the tests that would be reported as the final QC results.

    b. Out-of-specification or undesirable results were ignored and not investigated.

    c. Samples were retested without a record of the reason for the retest or an investigation. Only passing results were considered valid, and were used to release batches of APIs intended for US distribution.

    d. Unacceptable practices in the management of electronic data were also noted. The management of electronic data permitted unauthorized changes, as digital computer folders and files could be easily altered or deleted.

    View the original warning letter.


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  7. Warning Letter: Failure to follow Protocol (ucm 366762)

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    Protocol [redacted] required that you dispense a handheld electronic device (LogPad) to subjects at Visit 2, prior to surgery, and that the subjects record their pain assessments in the LogPad during the study. You did not dispense a LogPad to Subject 09-006 at Visit 2 on March 4, 2011, because the subject was sedated and on a ventilator. In addition, five pain assessments for Subject 09-006 were entered into the LogPad by the study coordinator, rather than by the subject. During the inspection, your study coordinator indicated that she used the subject’s login code and entered the subject’s pain-assessment scores into the LogPad when the subject was unable to provide a pain score. In your October 3, 2012, written response, you acknowledged that the LogPad was not dispensed to Subject 09-006 prior to surgery. You noted that after surgery, the subject was put on a “vent” (ventilator), was sedated, and was unable to participate in the evaluation of pain, via the LogPad or otherwise….

    …By failing to ensure that pain-assessment data were entered only by the subjects, as required by the protocol, you compromised the validity and integrity of data collected at your site. Protocol [redacted] required that the subjects record their pain assessments in the LogPad during the study. For Subject 09-006, the LogPad contained assessments purportedly made and entered by the subject; however, five pain assessments were entered by the study coordinator and reflect the study coordinator’s or nursing staff’s assessments, rather than the subject’s assessments.

    View the original warning letter.


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  8. Warning Letter: Hospital stretcher manufacturer failed to validate computer software (ucm 355751)

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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). Specifically, [redacted], developed by [redacted], is used to transfer and make changes to drawings used to manufacture devices. There is no protocol or documentation demonstrating that this software has been validated for its intended use.

    View the original warning letter.


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  9. Warning Letter: Failed to exercise appropriate controls (ucm 355294)

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    Additionally, during an audit of the data submitted in support of the [redacted] regarding [redacted] tablets USP [redacted] mg, our investigator requested to review the electronic analytical raw data to compare the values for [redacted] assay and degradation products. However, your firm provided only the printed copies of the raw data because your firm did not have the software program available to view the electronic raw data.
    Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

    During the inspection, our investigator also identified a backdated QC worksheet in the analytical report of [redacted] API raw material batch [redacted]. When your analyst affixed the related substance and IR weight printouts to the Format for Blank Sheet for Printout (Format No. F2/QCD/F/026-00), he signed and dated this worksheet as July 29, 2011. A second analyst, who reviewed this worksheet, also signed and dated it as July 29, 2011. However, your QA department did not issue this worksheet until July 31, 2011. Your analyst acknowledged during the inspection that he backdated this worksheet on July 31, 2011.

    Your response stated that the analyst incorrectly dated the worksheet as July 29, 2011, instead of July 31, 2011, and that there was no intention to deliberately backdate the document. However, your response contradicted your analyst’s backdating admittance during the inspection. In addition, your response did not explain the reviewer’s signature which was also dated July 29, 2011.
    Backdating documents is an unacceptable practice and raises doubt about the validity of your firm’s records.
    View the original warning letter.


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  10. Warning Letter: Failure to implement software upgrade (ucm 352318)

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    CAPA [redacted] was opened on May 25, 2011 to address Plum A+ pump battery failures which can cause a delay or interruption of critical therapy. Your firm has failed to  implement the identified corrective actions in this CAPA, such as a software upgrade to change the risk profile; battery replacement to reduce the probability of occurrence; battery supplier approval with increased controls; and notification to customers, despite the fact that your firm has received 311 complaints for code E321 documenting battery failures and 11 MDRs documenting a stoppage of critical drug delivery as of January 31, 2013. Plum A+ infusion pump: Review of the “analysis” data field for Plum A+ complaints revealed failures of the bubble sensor printed wire assembly within the printed circuit board, battery, touch key pad assembly and front case assembly.

    In addition, the failed components are not identified as a data source for analysis nor are they trended in your CAPA system to assess whether a preventive or corrective action is indicated and to ensure that components are performing according to infusion pump design specifications.

    View the original warning letter.


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