General Validation


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  1. Warning Letter: Failure to validate computer software for its intended use (ucm515403)

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    Your firm has not performed software validation [redacted]. These programs are used in the Starlight laser product family.

    b. The software validation for [redacted] is inadequate, in that the [redacted]. This message occurs when either the maximum voltage (6V) is exceeded, or the actual voltage is higher than the reference voltage associated with the intensity selected by the operator.

    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, your firm has not validated the following software used in its quality system:

    View the original warning letter.


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  2. Warning Letter: Failure to validate software (ucm465665)

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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, your firm uses the software [redacted], developed by [redacted], to document, maintain, and track customer complaints electronically. However, as stated by your firm’s Director of Quality Assurance (QA) & Regulatory Affairs (RA) during the inspection, the software does not generate time-stamped audit trails to independently record the date and time of operator entries and actions that create, edit, or modify electronic records.”

    View the original warning letter.


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  3. Notice of Concern from World Health Organization: Company Failed to Ensure Integrity of Data

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    ” Quotes from the Notice:

    The company failed to ensure the integrity of data:…
    Batch numbers were not electronically recorded…
    Hundreds of trial injections… in sequence… were seen in folder c:…
    Data was found to be deleted for several runs…
    The backups could not be restored during the inspection.
    Instrument audit trails were not available…
    An analyst was seen in process of taking tablet weight data from a calculation spreadsheet in Excel and writing the values down in his analytical test sheet as if these were the raw weighing values.”

    View the original Notice of Concern.


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  4. Warning Letter: Failure to establish and maintain procedures for validation (ucm436707)

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    “Your software development / validation does not include written procedures, structural and regression testing, and code reviews.

    1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,

    a. Your software development /validation:

      1. does not include written procedures covering the development/validation of the software used in your devices
      2. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
      3.  software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.

    ….

    c. The available clinical studies documentation for the following Evolution Oxygen Conservers:

        1. did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
        2. did not include the baseline saturation levels or the device settings for the patients.”

    View the original warning letter.


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  5. Warning Letter: Software specifications were not maintained (ucm429201)

    “A device master record has not been adequately maintained, as required by 21 CFR 820. 181. For example, specifications for the various components of the device were not maintained; software specifications were not maintained; production process specifications and procedures were not maintained; quality assurance procedures and acceptance criteria were not maintained; packaging and labeling specifications were not maintained; and installation, maintenance and servicing procedures and methods were not maintained.

    View the original warning letter .


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  6. Warning Letter: Failure to document digital changes and complaints (ucm421235)

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    No records of identification, validation or verification, review, or approval were available for design changes to the SimulCare resulting in the SimulCare II. The changes included new digital controls… Failure to ensure that suppliers and contractors were evaluated and selected based upon their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm utilizes various suppliers for components of your devices, including PCBs [Printed Circuit Boards]…your firm failed to record and document investigation of oral complaints related to burnt-out microchips… Specifically, the SimulCare II was cleared under K083202; however, your firm’s promotion of the device provides evidence that the device was modified including a change from analog knobs utilized to control the strength and duration of therapy to digital button controls now utilized for the same function.

    View the original warning letter.


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  7. Statement of Non-Compliance with GMP (from Italian Medicines Agency)

    • Reached the conclusion that fundamental GMP and regulatory requirements such as loss of data integrity, combined with insufficient management of data, change control system, supplier qualification, laboratory controls as well as the accuracy of data submitted, were not adequately implemented/considered…
    • Severe GMP violations related to the implementation of sound computerised systems in the quality control facilities were committed, that could lead/could have led to the falsification of data.

    View the original Statement of Non-Compliance


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  8. Warning Letter: Inadequate validation (ucm408746)

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    Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, your firm’s software validation testing for the Qube compact monitor (part number 91390) was conducted according to Design Validation Plan 91390 Salish Compact Monitor,819-0011-00, Rev. A, for the English and foreign language packs. There were multiple test case failures, yet your firm reported in Design Validation Report, 816-0099-02, that “the test results showed the product is acceptable and it meets the user requirements for patient monitoring.”…Your firm did not submit a current adequate validation for the software cited for the Qube compact monitor.

    View the original warning letter.


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  9. Warning Letter: Lack of spreadsheet control (ucm404316)

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    Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management.

    Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. In addition, your firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. Your firm’s lack of data control causes us to question the reliability of your data.

    View the original warning letter.


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  10. Warning Letter: Failure to validate software (ucm399525)

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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, your firm’s [redacted] Software Operating System used to log, evaluate, and investigate complaints, incoming, in process, and finished non-conformances was not validated to prevent deletions of records by employees.

    View the original warning letter


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