Software Validation


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  1. Warning Letter: Failure to validate software (ucm215449)

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    In addition, FDA noted nonconformance with regards to section 501(h) of the Act, 21 U.S.C. 351(h), due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part at 21 C.F.R. Part 820. These deviations include, but are not limited to, the following:

    • Failure to validate the device software for the RTVue OCT with NDB, software versions 3.5 and 4.0 as required by 21 CFR 820.30(g). Specifically: “a. Software 3.5 Version C, was tested between [redacted]. The test result shows a failure with sequence [redacted]. The failure was identified as [redacted], unreasonable video baseline, known “bug”.
    • Verification and Validation for Version D was approved on [redacted] to address the test result identified from the testing of software Version Verification and Validation testing was performed on software 3.5 Version D, on [redacted]. The report identifies a “Remaining Defect List” and Number [redacted] is identified as “Critical”, “Spectrometer Motor Error!” This software version was released on [redacted] without addressing defect number [redacted] and without supporting documentation software defect number [redacted] was corrected.
    • Verification and Validation test results/raw data for software 4.0, Version B, were performed on [redacted] and [redacted]. Sections of the test data were not performed, unsigned, and/or missing as follows: I. Section 16 – Cornea Module, not performed. II. Section 11 – Gridline Examine and Analyze, not performed. III. Section 10.2 – Verify [redacted] new function, unsigned and undated. IV. Section 15 – Combined Progression of [redacted] and [redacted] scans, a test sequence was not performed. V. Unidentified Section, raw test data missing. This test section is signed-off by an employee, with a completion date of [redacted].
    •  Electronic sign-off copy of the Verification and Validation Report for software 4.0, Version B. found the following: I. Section 16 – all sequence is entered as pass without supporting data to demonstrate the test was performed. II. Section 11 – all sequence entered as pass without supporting data to demonstrate the test was performed. III. Section 10.2 – contains an electronic signature of an employee, dated [redacted] IV. Section 15 – all sequence entered as pass without supporting data to demonstrate the test was performed. V. Section 3.1 – Verify Calibration Data is entered as being completed on [redacted] There is no supporting data to demonstrate sequence testing was performed. However, the last sequence test page of this test section is identical to a test performed by an employee on [redacted], not [redacted] as entered into the firm’s electronic sign-off copy.
    • Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed.

    View the original warning letter.


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  2. Warning Letter: Failed to validate input/output (ucm214564)

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    Your firm failed to check the accuracy of the input to and output from the computer or related systems of formulas or other records or data and establish the degree and frequency of input/output verifications. For example, the performance qualification of your [redacted] system software (Validation No. 4000-03-PQ-0002) failed to include verification of the expiration date calculations in the [redacted] system. In addition, there is no established degree and frequency of performing the verification. Discrepancy reports have documented that product labeling with incorrect expiration dates have been created and issued for use.

    View the original warning letter.


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  3. Warning Letter: Failure to document validation (ucm201895)

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    Failure to maintain a design history file for the “Defender” air filtration system, as required by 21 CFR § 820.300). Specifically, your firm  could not locate the design inputs, outputs, verification and validation documents, design reviews and design changes for the “Defender”.

    View the original warning letter.


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  4. Warning Letter: Failure to validate CAPA proedures (ucm201897)

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    Your firm’s Corrective and Preventive Action Practice form does not specify that you will verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device as required by 21 CFR § 820.100(a)(4). For example, your firm needs to perform effectiveness checks in order to verify that the corrective and preventive actions were effective  as to the intended purpose of the action and that new issues or concerns are not introduced.
    Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation as required by 21 CFR § 820.30(i). Specifically, your firm has failed to establish and maintain design control procedures for the design changes that were made to your devices during the months of May and June of 2009.

    View the original warning letter.


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  5. Warning Letter: Incomplete design validation (ucm200389)

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    Design validation failed to include testing of production units under actual or simulated use conditions as required by 21 C.F.R. 820.30(g). For example, the MedStar System design history records do not include documentation to demonstrate that the physiological data (e.g. blood pressure and heart rate readings) obtained from the patient is the identical data transmitted from the MedStar Collection Server.

    View the original warning letter.


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  6. Warning Letter: Lack of security for electronic data (ucm197966)

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    Your firm has not exercised 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 CFR 211.68(b)].

    For example, your firm lacks systems to ensure that all electronic data generated in your Quality Control laboratory is secure and remains unaltered. All analysts have system administrator privileges that allow them to modify, overwrite, and delete original raw data files on the [redacted] used [redacted] in the High Performance Liquid Chromatography (HPLC) units. There are no procedures that address the security measures in place for generation and modification of electronic data files for these instruments used for raw material, in-process, finished product and stability testing. In addition, your firm’s review of laboratory data does not include a review of an audit trail or revision history to determine if unapproved changes have been made.
    View the original warning letter.


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  7. Warning Letter: Failure to Automate Data Processing Systems (ucm190816)

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    You have failed 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 the production or the quality system, as required by 21 CFR 820.70(i). Specifically, there is no record of validation for software in the [redacted] which is used to make components for the aspirating dental injection syringes.

    View the original warning letter.


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  8. Warning Letter: Failure to validate off-the-shelf software (ucm185181)

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    Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses off-the-shelf software that generates the labels for the dental alloys. The off-the-shelf software has not been validated for this use.

    View the original warning letter.


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  9. Warning Letter: Failure to validate software (ucm185261)

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    Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 CFR § 820.70(i). For example, the [redacted] and [redacted] software used to generate instruction manuals, clinician’s manuals and prescription device labels for the [redacted] devices has not been validated.

    View the original warning letter.


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  10. Warning Letter: Faliure of validation process (ucm170224)

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    Your company did not ensure that its design verification and validation process detected design discrepancies with [redacted] the [redacted] printed circuit board (PCB) of the MTS trial stimulators using the [redacted] components that later caused loss of stimulation, and therefore, failure to complete trial implants.

    View the original warning letter.


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