Computer System


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Warning Letter: Failure to validate software (ucm076315)

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"The
validation of the software
used to perform the trend analysis has not been provided to support your firm's claim that the software can be used effectively to prevent the firm from overlooking complaints. In addition, you have not addressed how you corrected the observations that were made during the FDA inspection. Specifically, you have not
provided the documentation
of the investigation into the complaints that were identified in the FDA-483. Please provide for FDA review the documentation of investigation into the complaints, revised procedure QSP8.2-2 "Customer Complaints," and the software validation that was performed on the complaint handling software used for trend analysis.

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Warning Letter: Failure to record in audit trail (ucm076260)

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On January 11, 2006, during content uniformity testing of[redacted], the analyst noticed that the first two capsules were out-of-specification

and the run was aborted. The audit trail for the laboratory data acquisition system does not indicate that the run was aborted and the analyst did not print the sample results or record the failing results in the laboratory notebook.

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Warning Letter: Lack of procedures and instructions (g6173d)

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Warning Letter: No validation protocol (g6139d)

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"Failure to use the design process for the design changes made to the Biad nuclear imaging system and failure to have written design change control procedures. [21 CFR 820.30(i)] Specifically, the design change (retrofit) your firm made to the Biad nuclear imaging system as a result of a complaint that the detector head on the Biad nuclear imaging system fell and trapped a patient (See item #1 above) was not performed using design controls. There is no formal approval of the change, no risk assessment was documented, and there is
no verification/ validation protocol
."

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Warning Letter: Lack of user level security (g5973d)

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Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel [21 CFR § 211.68(b)]. Specifically:

a) Laboratory managers (QC and R&D) gained access to the [redacted] computer system through a common password. Analysts were not required to use individual passwords; they operated the system following the login by the laboratory managers.

b) Due to the common password and lack of varying security levels, any analyst or manager has access to, and can modify any HPLC analytical method or record. Furthermore, review of audit trails is not required.

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Warning Letter: Failure to maintain accurate, complete, and current records (ucm075362)

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The deviations noted on the FDA-483, your written responses to those deviations, and issues from our subsequent review of the inspection report are discussed below.

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Warning Letter: Failure to follow 21 CFR 11 compliance (g5276d)

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Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr.  [redacted] that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you to Mr. [redacted], dated January 31, 2005, detailed the name of the EMR system and the means by which study subject information is entered. Please note that Title 21, Code of Federal Regulations, Part 11, “Electronic Records; Electronic Signatures ” outlines specific requirements that must be met for any system that is being used to maintain required records. In addition to the information requested above, please submit the following:

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Warning Letter: Incomplete requirements (ucm075276)

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Your firm failed to address design input requirements that are incomplete, as required by 21 CFR 820.30(c) [FDA-483, Item 31. Specifically,

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Warning Letter: Failure to validate(g4689d)

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"Your firm failed to
validate and approve processes
whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). Your firm failed to validate the following operations c) Validation of Borland Compiler is incomplete because
software used to control passwords
was not addressed (FDA 483, Item #3)."

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Warning Letter: Failure to Create Validation and CAPA Procedures (g4452d)

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Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) and (b). For-example:

a. The procedure titled corrective Action Handling [redacted] was not approved and implemented to address corrective and preventive action and no established procedure was found to have been in place.

b. Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program.

A report dated November 11, 2002 on non-conforming material on [redacted] was filed and a possible cause for the [redacted] was given; however no documentation was provided to verify or validate the adequacy of the corrective and preventive actions.

Problems were recorded relating to the use of the new dosing/dispensing machine [redacted]; however no documentation/evidence was provided
to verify or validate the adequacy of the corrective and preventive actions.”

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