Warning Letter: Computer systems not validated (s6381c)

Tags: Computer System | Failure to Validate Software | Medical Device Manufacturer | Spreadsheet
May 17, 2007
 
"Software used as part of the production quality system for its intended use according to an established protocol [21 C.F.R. 820.70(i)]. Specifically,
 
(a) intended to check for outliers and calculate mean, SC, % CV, value assignments for finished devices.
(b) Complaint handling software
(c) Quantrol database program"

 

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Warning Letter: Failure to validate computer software (s6338c)

Tags: Computer System | Medical Device Manufacturer | Software Validation Inadequate
April 24, 2007

Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, electronic records are used, but there was no software validation. No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software used in creating and maintaining nonconformance records, product return records, internal audit corrective action records, or preventive action records. View the original warning letter.

Warning Letter: Failure to validate before implementation (s6328c)

Tags: Computer System | Failure to Validate Design | Medical Device Manufacturer
April 23, 2007
 
"Failure to 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). Specifically: a) In June 2006, your firm recalled 2455 units of the Spectrum Infusion Pump due to several events where the pump tubing mis-loaded when it was installed by the end user. Several design changes were made to the Spectrum Pump's hardware and software to better assist the end user in installing the pump tubing. These design changes were incorporated into the blanket Engineering Change Notice (ECN # 15501). This ECN contained several individual ECNs to cover each change that was made to correct the tubing mis-loading problem. However, the blanket ECN also included an individual ECN to implement the PCA/PCEA delivery modes within the Spectrum pump. ECN# 15501 and all individual ECNs under this blanket ECN were cleared for manufacturing on May 01, 2006. However, our inspection revealed the for the pump operating software version 4.00.04 and MDL software version 5, and the design of the hardware components associated with the PCA/PCEA module were not completed at the time the re-designed Spectrum pump was released for manufacturing. Yet, ECN # 15501 was approved for manufacturing by your firm's Approval Committee (consisting of representatives from Engineering, Manufacturing, Quality Assurance and Purchasing), without ensuring that the appropriate verification/validation for the PCA/PCEA functions were completed. More significantly, 257 units of the Spectrum pumps, manufactured between May 01, 2006, and June 26, 2006, were distributed into interstate commerce with an "enabled" version of this unvalidated PCA/PCEA function as replacements for defective devices that were returned to Sigma International as a result of the June 2006 recall."

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Warning Letter: Failure to validate software (ucm076315)

Tags: Computer System | Medical Device Manufacturer | Software Validation Inadequate
March 2, 2007
 
"The 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 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: Lack of procedures and instructions (g6173d)

Tags: Computer System | Failure to Validate Software | Inadequate/Missing Procedures | Medical Device Manufacturer
December 8, 2006

• Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use according to an established protocol. For example, databases that are maintained for data analysis and other tracking and trending functions, including complaint and services access databases, have riot [sic] been validated for their intended use.
• Failure to establish and maintain instructions and procedures for performing and verifying that servicing meets the specified requirements, as required by 21 CFR 820.200(b). Each manufacturer must analyze service reports with appropriate: statistical methodology in accordance with Section 820. 100. For example, your quality group reviews narrative summaries of service reports every two weeks, but the data is not tracked and trended according to a statistical method.

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Warning Letter: No validation protocol (g6139d)

Tags: Computer System | Design Validation Inadequate | Medical Device Manufacturer
November 21, 2006
 
"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 ."

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

Tags: Computer System | Inadequate/Missing Procedures | Investigator Responsibilities | Medical Device Manufacturer
April 11, 2005

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:

• Documentation of the validation of your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records;
• Documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency;
• Documentation of a secure, computer-generated, time-stamped audit trail that can independently record the date and time of operator entries and actions that create, modify, or delete electronic records, and to verify that record changes do not obscure previously recorded information.

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Warning Letter: Incomplete requirements (ucm075276)

Tags: Computer System | Inadequate/Missing Procedures | Medical Device Manufacturer | No Procedure for CAPA
February 7, 2005

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

• Functional requirements for the DBSS are in some cases very high level. For example, the requirements for Donor Reporting merely state that the application must enable the user to identify, from a list of persons, the donor on whom the report should be based, and to print an Autologous Unit Status Report, a Donor History Report, a Person Audit Trail Report, a Deferral Audit Trail Report, and an Individual Donor Orders Report for a specific donor. The requirements do not address the files to be accessed, the fields to be printed, or the format of the ave been written for problems with these reports. [redacted] have been written for problems with these reports. For example, [redacted] concerns the military personnel’s SSN appearing where the donor’s SSN should appear on the Donor Audit Trail Report.”

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Warning Letter: Failure to validate(g4689d)

Tags: Computer System | Medical Device Manufacturer | Software Validation Inadequate
April 20, 2004
 
"Your firm failed to 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 was not addressed (FDA 483, Item #3)."

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

Tags: Computer System | Failure to Validate Software | Medical Device Manufacturer | No Procedure for CAPA | Spreadsheet
December 23, 2003

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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