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    1. 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].

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    2. 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).

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    3. Warning Letter: Failure to capture electronic data (ucm399364)

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      AMKS TRL monitoring failed to identify and correct a clinical investigator’s failure to collect study subjects’ data on protocol-specific case report forms (CRFs), as required by Protocol [redacted]. We note that during the inspection, you indicated that AMKS TRL did not use any paper CRFs or electronic data capture to record study subjects’ data.

      View the original warning letter.

       

       


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    4. 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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    5. Warning Letter: Mishandling and retrieval of electronic data (ucm393093)

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      Your firm failed to establish SOPs describing the handling and retrieval of electronic data. Handling of electronic data includes the security (e.g., audit trails) and statistical analysis of raw data. Specifically, the SOP for handling electronic data should describe a procedure for the archiving of multiple statistical analyses of the clinical pathology raw data with the study records. For Study [redacted], multiple sets of statistical analyses were maintained on the firm’s electronic server, and were not archived appropriately.

      View the original warning letter.


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    6. Warning Letter: Failure to follow procedures (ucm401361)

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      The FFDM manufacturer QC (excluding monitor and printer QC) procedures for digital unit 3, Lorad (Hologic), SEL, room Mammography were not followed. [See 21 CFR 900.12(e)(6)]

       

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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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