Software Validation


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  1. Warning Letter: No records demonstrating the software was validated (ucm459656)

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    “Failure to establish and maintain design validation procedures 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).

    During an inspection of your firm located in Round Rock, Texason June 16, 2015 through July 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the ECG Check Application and ECG Check Wireless Lead Cardiac Monitor (ECG Check Monitor)…

    Your firm’s “Design Validations” procedure Revision 1 dated May 22, 2015, states software should be tested according to a test plan and requires the results of this software validation to be maintained in the design history file (DHF). Your firm does not have any records demonstrating the ECG Check Application software was validated.”

    View the original warning letter.


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  2. Warning Letter: Failure to adequately validate software (ucm441879)

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    “Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol as required by 21 CFR 820.70(i). Specifically, you did not validate your CNC Lathe and MAS 90 software used in manufacturing and labeling, respectively.”

    View the original warning letter.


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  3. Warning Letter: Failure to follow SOP/Lack of controls (ucm401451)

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    1. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

    Your firm lacked accurate raw laboratory data records for API batches shipped by your firm. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, your quality control (QC) laboratory failed to include complete data on QC testing sheets. Failing or otherwise atypical results were not included in the official laboratory control records, not reported, and not investigated.

    Your firm’s response to the Form FDA-483 acknowledges the deficiencies regarding data integrity observed during this inspection. Nevertheless, your firm’s health hazard evaluation “Drug Safety Analysis” conducted in response to the Form FDA-483 concluded that there was no effect on product quality or patient safety. However, this evaluation was based on unreliable and incomplete data, as undesired records appear to be excluded. For instance, your report failed to include all of the batches tested, and did not list all of the customers you notified other than Apotex, Inc. Your response to the previous 2010 inspectional findings stated that “We are confident that … SOPs covering OOS … and Deviation … will provide the necessary control over the system to ensure consistent application and on-going compliance to this requirement.” However, you clearly failed to detect and investigate the inaccurate data found by our investigators during this recent inspection.

     

    View the original warning letter.


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  4. Warning Letter: Failure to adequately validate software (ucm399011)

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    Failure to adequately validate software used as part of production and the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, actions were not taken to ensure that computer errors would not result in the loss of dosimetry and run dose data from the Dosimetry Measurement Application (DMA) module of [redacted].

    View the original warning letter.


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  5. Warning Letter: Failure to perform validation of device software (ucm402449)

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    Failure to perform validation of device software, as required by 21 CFR § 820.30(g). Specifically, your firm failed to validate the software calculator for the STAAR Visian MICL Lens (ICL models MICL 12.1 mm, MICL 12.6 mm, MICL 13.2 mm, MICL 13.7 mm).

    View the original warning letter.


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  6. 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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  7. Warning Letter: Failure to validate computer software (ucm399523)

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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).

    View the original warning letter.


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  8. Warning Letter: Failure to validate computer software (ucm399519)

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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, during the inspection your firm confirmed that its software program [redacted] version [redacted] released on August 28, 2009, for documenting condom production control tests has not been validated for its intended uses.

    View the original warning letter.


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  9. Warning Letter: Failure to validate computer software (ucm377116)

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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 [redacted] to generate, store, and disseminate standard operating procedures, forms, and other records. [redacted] is also used by your firm to generate and store Device History Records (DHRs) and other quality system data. During the inspection, your firm indicated that the procedure titled, “Validacion del software utilizado en el sistema de calidad, GC-E-07-49, Rev. 00,” dated March 14, 2011, states that validation is concentrated on software and documents used in the quality system since there is no software used in your firm’s manufacturing equipment. However, your firm could not produce any evidence to demonstrate that the software programs were validated for their intended use.

    View the original warning letter.


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  10. Warning Letter: Failure to validate computer software (ucm377097)

     
    “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: Document No. IN-26_01_002, No. 1, dated March 25, 2013, Validierungsmasterplan [Validation Master Plan] developed as part of CAPA 2335, states that [redacted], [redacted], and [redacted], are software programs that are considered critical, which requires software validation. These programs have not been validated by your firm.”

    View the original warning letter.


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