Warning Letter: Failure to validate computer software (ucm256890)

Failure to validate computer software for its intended use in production according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented as required by 21 C.F.R. § 820.70(i). For example, your firm failed to validate, according to established procedures, the automated mills and lathes that are used in the manufacturing of components for the PL5 2008 medical laser. Your firm installed [redacted]automated mills and one automated lathe during December, 2006 but your firm could not provide an established validation protocol for the validation of the automated systems or provide any documentation that showed the systems and their controlling software that were used in the manufacture of metal and plastic components of the PL5 Medical Laser were validated. 5. Failure to establish and maintain adequate procedures for validating the device design that includes software validation and risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g).

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Warning Letter: Software not validated (ucm239465)

Failure to validate, for its intended use, computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has not validated the software used for generating product labels.

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Warning Letter: Software has not been validated (ucm227058)

The [redacted] Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.

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Warning Letter: Failure to validate software (ucm215449)

In addition, FDA noted nonconformance with regards to section 501(h) of the Act, 21 U.S.C. 351(h), due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part at 21 C.F.R. Part 820. These deviations include, but are not limited to, the following:

• Failure to validate the device software for the RTVue OCT with NDB, software versions 3.5 and 4.0 as required by 21 CFR 820.30(g). Specifically: “a. Software 3.5 Version C, was tested between [redacted]. The test result shows a failure with sequence [redacted]. The failure was identified as [redacted], unreasonable video baseline, known “bug”.
• Verification and Validation for Version D was approved on [redacted] to address the test result identified from the testing of software Version Verification and Validation testing was performed on software 3.5 Version D, on [redacted]. The report identifies a “Remaining Defect List” and Number [redacted] is identified as “Critical”, “Spectrometer Motor Error!” This software version was released on [redacted] without addressing defect number [redacted] and without supporting documentation software defect number [redacted] was corrected.
• Verification and Validation test results/raw data for software 4.0, Version B, were performed on [redacted] and [redacted]. Sections of the test data were not performed, unsigned, and/or missing as follows: I. Section 16 – Cornea Module, not performed. II. Section 11 – Gridline Examine and Analyze, not performed. III. Section 10.2 – Verify [redacted] new function, unsigned and undated. IV. Section 15 – Combined Progression of [redacted] and [redacted] scans, a test sequence was not performed. V. Unidentified Section, raw test data missing. This test section is signed-off by an employee, with a completion date of [redacted].
•  Electronic sign-off copy of the Verification and Validation Report for software 4.0, Version B. found the following: I. Section 16 – all sequence is entered as pass without supporting data to demonstrate the test was performed. II. Section 11 – all sequence entered as pass without supporting data to demonstrate the test was performed. III. Section 10.2 – contains an electronic signature of an employee, dated [redacted] IV. Section 15 – all sequence entered as pass without supporting data to demonstrate the test was performed. V. Section 3.1 – Verify Calibration Data is entered as being completed on [redacted] There is no supporting data to demonstrate sequence testing was performed. However, the last sequence test page of this test section is identical to a test performed by an employee on [redacted], not [redacted] as entered into the firm’s electronic sign-off copy.
• Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed.

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Warning Letter: Failure to document validation (ucm201895)

Failure to maintain a design history file for the “Defender” air filtration system, as required by 21 CFR § 820.300). Specifically, your firm  could not locate the design inputs, outputs, verification and validation documents, design reviews and design changes for the “Defender”.

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Warning Letter: Failure to Automate Data Processing Systems (ucm190816)

You have failed 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 the production or the quality system, as required by 21 CFR 820.70(i). Specifically, there is no record of validation for software in the [redacted] which is used to make components for the aspirating dental injection syringes.

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Warning Letter: Failure to Validate Spreadsheets (ucm185865)

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, when requested, no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs.

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Warning Letter: Failure to validate off-the-shelf software (ucm185181)

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 off-the-shelf software that generates the labels for the dental alloys. The off-the-shelf software has not been validated for this use.

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Warning Letter: Failure to validate software (ucm185261)

Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 CFR § 820.70(i). For example, the [redacted] and [redacted] software used to generate instruction manuals, clinician’s manuals and prescription device labels for the [redacted] devices has not been validated.

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Warning Letter: Failure to validate software (ucm173977)

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). This was a repeat violation from a previous FDA-483 that was issued to your firm. For example: A) Your firm uses off-the-shelf software (HEAT Help Desk) to manage customer support service calls and to maintain customer site configuration information; however, your firm failed to adequately validate this software in order to ensure that it will perform as intended in its chosen application. Specifically. your firm’s validation did not ensure that the details screen was functioning properly as intended. The details screen is used to capture complaint details and complaint follow-up information which would include corrective and preventative actions performed by your firm when service calls are determined to be CAPA issues. B) Off-the-shelf software (Microsoft SharePoint) is being used by your firm to manage your quality system documents for document control and approval. However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses. Specifically. at the time of this inspection there were two different versions of your CAPA & Customer Complaint procedure, SOP-200-104; however, no revision history was provided on the SharePoint document history. Your firm has failed to validate the SharePoint software to meet your needs for maintaining document control and versioning.

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