Warning Letter: Inadequate software validation (ucm323748)

The Verification Test for the Programming/Verification of code chips (no document control number) dated 4/21-22/2005 is inadequate in that: i. There is no document control number . ii. Step 6 of the verification test requires a repeat of the step [redacted] times, [redacted] for a total of sample size of [redacted]. Instead, the protocol/raw data indicates only [redacted] blank code chips were utilized to conduct the programming/code chip download challenge (i.e., [redacted] chips for each of the [redacted] code chip types). iii. Upon download of the code chip information, there was no verification activity to ensure that the integrity of the performance data, which is unique to each lot code, was not compromised. iv. The raw data associated with the download challenge/programming of the [redacted] chip is missing from the Programming/Verification of Code Chips documents.

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Warning Letter: Failed to validate computer software (ucm178264)

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).

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Warning Letter: Failure to validate computer software (ucm319510)

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 a quality system, according to established procedure, as required by 21 C.F.R. 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Sorting software for decay calculations on brachytherapy seeds sorted into inventory. There are no software verification and validation requirements defined in your firm’s procedures, and there are no records documenting that the Sorting software is fully validated for its intended uses.

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Warning Letter: Failure to provide validation documentation (ucm293443)

Failure to validate computer software used as a part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm could not provide any documentation to demonstrate that the software used for the 6111 PCB (Printed Circuit Board) check machine [redacted] was validated for its intended use. Your firm’s Department Manager of Regulatory Affairs stated that the software used for the PCB check machine has not been validated.

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Warning Letter: Failure to establish procedures (ucm279058)

Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

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Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example: Your firm does not have a purchasing control procedure and has not evaluated the contract manufacturer to ensure that manufacturing processes are appropriately validated. In addition, there are no maintenance procedures in place, nor has your firm established procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

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Warning Letter: Failure to exercise appropriate controls (ucm279058)

Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: a. Your firm did not put in place requirements for appropriate usernames and passwords to allow appropriate control over data collected by your firm’s computerized systems including UV, IR, HPLC, and GC instruments. All employees in your firm used the same usemame and password. In addition, you did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data or the functionality of the software used to determine test results. b. Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date. In your response, you state that you will maintain backup of electronic raw data and all technicians will have their own user identification (ID) and password.

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Warning Letter: Failure to establish procedures (ucm279180)

Failure to establish and maintain adequate procedures for the 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: the device design was revised to include an [redacted] for both the ActiveCare DVT and ActiveCare+SFT devices. Your firm’s design validation report No.71365539, Safety Technical Report OVP, includes design verification test results where the device was tested at [redacted] but does not appear to include testing of production units under actual or simulated conditions as indicated in your Design Verification and Validation procedure referenced in your Design Changes Procedure.

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Warning Letter: Failure to establish adequate procedures(ucm271368)

Failure to establish adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, testing records for timers received on March 27, 2009; April 9, 2009; April 17, 2009; and May 28, 2009, only included a computer printout of the final data as the original raw data of the testing conducted and acceptance data for each of the timers were not maintained.

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Warning Letter: Failure to establish validation procedures (ucm268244)

Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

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Warning Letter: Failure to establish procedures (ucm268059)

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures. You also have no documentation of design validation or design change controls for the Antalgic-Trak, including no documentation of risk analysis or structural [redacted] testing of the embedded software.

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