Software Validation


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  1. Warning Letter: Failure to document changes (ucm 348651)

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    During our inspection, a Red Blood Cell component was identified as being in quarantine according to an electronic inventory inquiry on January 30, 2013. However, the component could not be located in the expected physical quarantine location. After the discrepancy was identified by our investigators, a search was initiated and the component was found in the discard bin. The component had been physically discarded without maintaining a record of the discard as required by TS 500-2, Final Disposition of Blood Components. Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)].

    View the original warning letter.


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  2. Warning Letter: Labeling software is not defined in SOP (ucm 352769)

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    Your firm’s product labeling procedure has not been adequately implemented as required by 21 CFR § 820.120. Specifically, you lack documented approval for your vacuum therapy device; labeling software is not defined in your standard operation procedure; and device history records lack the primary label/labeling.

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  3. Warning Letter: eCRF lacks laboratory values (ucm340269)

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    As an investigator, you are responsible for maintaining accurate, complete, and current records relating to the investigation. (See 21 CFR 812.140(a)). You failed to adhere to the above-stated regulations. Examples of these failures include, but are not limited to the following: a. (b)(6) • The Electronic Case Report Form (eCRF) lacks baseline vital signs, permanent pacemaker) interrogation findings, or laboratory values.

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  4. Warning Letter: Failure to follow procedure (ucm342736)

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    Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example, the design control procedure (P03 02) requires that design reviews be completed at the end of the completion of all technical documentation. The design review for the Lady Comp device was completed June 16, 2008, prior to the completion of the software qualification for the Lady Comp device, which was completed October 17, 2008. No design review was conducted after the software qualification. The adequacy of your firm’s response, dated October 26, 2012, cannot be determined at this time. Your firm completed a new design review for the Lady Comp device that included software validation. Additionally, your firm stated that training would be conducted on the current design review procedure. However, the evidence of implementation to include the training documentation was not provided in the response.

    View the original warning letter.


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  5. Warning letter: Failure to validate (ucm337808)

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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 custom automatic machines in the needle production process. Your firm stated that it performed software validation for the automatic machines and that the software protocol was tested, but these validation activities were not documented.

    View the original warning letter.


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  6. Warning Letter: Failure to validate computer software (ucm340155)

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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: There is no evidence that validation was completed for the [redacted] software used by your firm to provide the customer with the graphic representation of the flow rate of the device. [redacted], indicated that your firm did not have user requirements, input, or output requirements for the [redacted] software.

    View the original warning letter.


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  7. Warning Letter: Failure to implement SOP (ucm336120)

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    Specifically, your firm has no standard operating procedures implemented to determine if the complaint received represents an MDR reportable event.  Your firm documents complaints in a computer system called [redacted]; however, this practice is inadequate because you failed to implement a standard operating procedure… Failure to implement procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.  Specifically, your firm failed to define, document, and implement purchasing control procedures to ensure the Nurse Call hardware purchased from your contract manufacturer conforms to your firm’s specified requirements.

    • Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1).  For example, your firm failed to establish and maintain written procedures to control the design process, including requirements for design inputs, design outputs, design reviews, design verification/validation, design transfer and design changes for the Nurse Call and Focus devices.

    View the original warning letter.


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  8. Warning Letter: Newer Software not validated (ucm340300)

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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 and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example: Your firm’s design validation procedures outlined in Section 4.6 of the Design Control Procedure, Doc. No. [redacted] do not ensure that the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation are documented in the Design History File (DHF). Thirty test records from a clinical study conducted as part of the design validation for the AnyView A8 Monitor were reviewed. The results of the design validation, including the identification of the design, the unit tested, the date, and the individuals performing the validation were not documented. In addition, the investigator noted that a software revision had since occurred; however, your firm admitted that the newer software version had not undergone software validation.

    View the original warning letter.


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  9. Warning Letter: Failure to report significant software changes (ucm339489)

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    Specifically, the Alcon LenSx Laser System was cleared via K101626, with operating software version 2.02. Your firm has since made multiple revisions to the software, and the LenSx Laser System was running software version 2.13 at the time of the inspection. FDA reviewed your software changes from version 2.02 to version 2.13 and determined that some changes are significant with respect to your original premarket clearance submission and may affect the safety and efficacy of the device. A new 510(k) is required for these changes. … It is your responsibility to report to FDA all significant modifications, including software changes that may change the design or performance and/or affect the safety and efficacy of your devices.

    View the original warning letter.


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  10. Warning Letter: No Corrective Action validation plan (ucm332838)

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    Your firm had not completed any corrective or preventive actions and had not evaluated the effectiveness of your supplier’s corrective actions… E.    Failure Investigation and Corrective/Preventive Action Form No. 497, dated 08/02/2011, stated that DPM Central Station had a software anomaly which caused the trend data for a patient to be replaced by another patient.  On 05/12/2011, your firm released a product correction letter to the field to correct the issue via a software upgrade.  The CAPA effectiveness verification method was identified as verifying that all documents in the corrective action have been modified.  However, your firm was not able to provide any documentation to demonstrate that the CAPA has been verified for effectiveness and that it does not adversely affect the finished device.

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