Software Validation


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  1. Warning Letter: Computers have not been validated (ucm331623)

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    • Failure to establish and maintain corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, there are no written Corrective and Preventive Action procedures.

    • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, there are no written complaint procedures.

    We reviewed your firm’s response and concluded it was not adequate. Although the response states complaint procedures are being established, there is no indication the software to be installed on the service technicians computers has been validated. In addition, a systemic corrective action is not addressed in your response.

    View the original warning letter.


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  2. Warning Letter: No software validation (ucm330805)

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    Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include requirements for (1) analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary; (2) investigating the cause of nonconformities; (3) identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems; (4) verifying and validating corrective and preventive actions to ensure that the actions do not adversely affect the products; (5) implementing and recording changes necessary to correct and prevent identified quality problems; and (6) disseminating information related to quality problems and nonconforming product, as required by 21 CFR 820.100(a).
    For example, review of three out of [redacted] Corrective and Preventive Action (CAPA) records revealed:

    a) Q-case #[redacted] concerned [redacted]. Your firm’s investigation identified and processed the corrective actions as a production nonconformance, but statistical methods were not used to quantify the problem. The corrective action of [redacted] was implemented, but validation was not conducted or documented to ensure that the corrective actions was effective and did not adversely affect the product.

    View the original warning letter.


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  3. Warning Letter: Inadequate software validation (ucm323748)

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    The Verification Test for the Programming/Verification of code chips (no document control number) dated 4/21-22/2005 is inadequate in that: i. There is no document control number . ii. Step 6 of the verification test requires a repeat of the step [redacted] times, [redacted] for a total of sample size of [redacted]. Instead, the protocol/raw data indicates only [redacted] blank code chips were utilized to conduct the programming/code chip download challenge (i.e., [redacted] chips for each of the [redacted] code chip types). iii. Upon download of the code chip information, there was no verification activity to ensure that the integrity of the performance data, which is unique to each lot code, was not compromised. iv. The raw data associated with the download challenge/programming of the [redacted] chip is missing from the Programming/Verification of Code Chips documents.

    View the original warning letter.


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  4. Warning Letter: Failure to validate computer software (ucm319510)

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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 a quality system, according to established procedure, as required by 21 C.F.R. 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Sorting software for decay calculations on brachytherapy seeds sorted into inventory. There are no software verification and validation requirements defined in your firm’s procedures, and there are no records documenting that the Sorting software is fully validated for its intended uses.

    View the original warning letter.


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  5. Warning Letter: Failure to provide validation documentation (ucm293443)

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    Failure to validate computer software used as a 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 could not provide any documentation to demonstrate that the software used for the 6111 PCB (Printed Circuit Board) check machine [redacted] was validated for its intended use. Your firm’s Department Manager of Regulatory Affairs stated that the software used for the PCB check machine has not been validated.

    View the original warning letter.


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  6. Warning Letter: No contols over computer system (ucm278262)

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    Your firm has failed to exercise appropriate controls over computer or related systems to assure that the input to and output from the computer or related systems of formulas, other records, or data, are checked for accuracy [21 C.F.R. § 211.68(b)]. For example, your firm’s custom software for your Master Batch Production record, referred to as the “I-131 Database,” has not been validated. This software is responsible for generating the batch production record, performing calculations to produce varying concentrations of drug product, and generating label information for customer vials and lead pigs.

    View the original warning letter.


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  7. Warning Letter: Failure to establish validation procedures (ucm268244)

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    Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

    View the original warning letter.


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  8. Warning Letter: Failure to validate computer software (ucm265239)

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    Failure to validate computer software for its intended use according to an established protocol , as required by 820.820.70(i). Your firm uses the [redacted] for in-process and final product testing for the [redacted] and the [redacted]. Your firm conducted software validation for the [redacted] and the results are included in the Software Validation Report, dated February 11, 2010.

    View the original warning letter.


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  9. Warning Letter: Failure to document software validation (ucm258853)

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    Failure to adequately document software validation activities and results for computers or [redacted] systems used as part of production, as required by 21 CFR 820.70(i). For example, there is no documentation of validation having been performed on the software systems that operate the [redacted], which moves [redacted] pallets from [redacted] to shipping[redacted]. There are no documented quality system procedures for the control of the [redacted] finished product warehouse (UP [redacted]) and your firm’s [redacted] department does not operate within your firm’s quality system.

    View the original warning letter.


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  10. Warning Letter: Failure to provide validation documentation (ucm257575)

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    Failure to establish and maintain procedures for validating the device design, i.e. software validation , which is required by 21 CFR 820.30(g). For example, your firm did not establish a software validation procedure or a software validation plan for software version 12.1. We acknowledge, since the release of software version 12.1 on August 27, 2008, that you have conducted a retrospective software validation for software versions 10.14-12.1; however, this was not conducted until June 8-August 20, 2010. Additionally, our inspection noted these “retrospective” testing activities lacked testing activities typically performed during a software validation, such as updated software requirements specification, a source code evaluation, and user site testing.

    View the original warning letter.


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