Warning Letter: Failure to establish and maintain procedures for validating device software (ucm474240)

 
“Failure to establish and maintain procedures for validating the device software for infusion pumps to ensure that devices conform to defined user needs and intended uses.”

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Warning Letter: No active audit trail (ucm443247)

“Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.

You lacked controls to prevent the unauthorized manipulation of your laboratory’s electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data. Furthermore, the computer software for this equipment lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change. Audit trails that capture such critical data about the quality of your batch production should be reviewed as part of the batch review and release process.”

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Warning Letter: Failure to develop adequate written procedures (ucm442577)

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, Your procedures addressing corrective and preventive actions, “Procedures for Corrective and Preventive Action”, PCPA-00, dated10/5/10 and “Measurement and Analysis” procedure, MA-00, dated 10/5/10, are not adequate in that: a) Your procedures do not address:

1. How and how often each data source will be analyzed to identify existing and potential causes of nonconforming product.

2. Initiating a corrective and preventive action commensurate with the significance and risk of the nonconformity.

3. Verifying and validating corrective and preventive actions to ensure such action is effective and does not adversely affect the finished device.

4. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.

…
5. Failure to establish and maintain procedure for identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, a sticky note on the “Chaps” instructions sheet stating “No Longer Need F Velcro Lengths” is the only documentation for the change to receive the elastic with the Velcro already sown onto it. This design change did not go through your formal change control as required by “Change Control” procedure, CC-00, dated 10/5/10.

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Warning Letter: Failure to establish and maintain procedures for validation (ucm436707)

“Your software development / validation does not include written procedures, structural and regression testing, and code reviews.

4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,

a. Your software development /validation:

1. does not include written procedures covering the development/validation of the software used in your devices
2. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
3.  software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.

….

c. The available clinical studies documentation for the following Evolution Oxygen Conservers:

1. did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
2. did not include the baseline saturation levels or the device settings for the patients.”

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Warning Letter: Failure to update procedure (ucm466038)

 
“Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b).  For example, your firm completed design change note 798 to modify the moor VMS-LDF device and updated the software from version 1 to version 2.  Work instruction procedure, “[redacted]”, states that version 1 is uploaded onto the device during the main board testing operation.  However, your firm did not update the work instructions to address the software version change.”

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Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

“Failure to establish and maintain procedures to control all documents, as required by 21 CFR
820.40. For example, your firm failed to follow its Documentation Management procedure since it
used electronic signatures to approve numerous procedures. Your firm’s procedure states that
there are no currently-approved electronic signature systems implemented at your firm.”

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