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Venturi Ventilator, provides a software that continuously adaptsto the patient’s changing breathing demands and assures ventilation at the lowest pressure. Recall #Z-803-9. REASON Software error may cause ventilator to deliver more than set tidal volume. CODE Venturi Ventilator with Software Revision C. Serial #970222. MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut. RECALLED BY Manufacturer, by letter on...
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Lumisys 5/12/98 MammoWorks” an interactive database designed for mammography practices and teleradiology devices. 1. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications [21 CFR 820.70]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that your production process...
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DeRoyal Cientifca Esophageal Stethoscopes 5/1/98 “1. 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 would also be a violation of the GMP Regulation, 21 CFR...
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Failure to establish adequate written-recall procedures and to validate the computer software programs designed to facilitate recall of distributed drug products.
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Information Management System for Mammography Practices. Recall #Z-187-9. REASON The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam. CODE All copies of Mammoworks Version 2.6. MANUFACTURER Lumisys, Inc., (formerly Compurad), Tucson, Arizona. RECALLED BY...
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Bioresearch 3/31/98 TMJ diagnosois software Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that...
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Hitachi 3/30/98 In vitro diagnostic analyzers 1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) (4). This would be a violation of the 1978 Good Manufacturing Practices Regulation, 21 CFR 820.162, inadequate failure investigation. For example, software release versions were not documented as required or...
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.Controls on your laboratory computer system software _____ allow saved chromatograms to be re-integrated without designation as a saved file. The saved chromatograms that are re-integrated then cannot be restored as original data. SoftwareCPR Keywords: Part 11
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ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostictests. Recall #Z-363-9. REASON Software errors for V1.0 which could lead to erroneous test results. CODE All lot numbers for the ACS Centaur. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete. DISTRIBUTION Germany and Italy....
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3/17/98 Recon Rx neurological biofeedback monitoring1762 units Rx unit were not functioning correctly. Obsolete version 3.01 software had been installed in the units.
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… Failure to ensure that automatic, mechanical, and electronic equipment, including computer(s) are inspected or checked according to a written program designed to assure proper performance [21 CFR 211.68]. For example, your computer software used for tracking raw material, finished product quarantine/release, and archiving master formulas has not been validated…. SoftwareCPR Keywords: Drug, Pharma
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Scottcare 2/25/98 TeleRehab II Cardiopulmonary Monitoring System Failure to maintain a complete Device History Record (DHR) in that it does not contain updates to software or their location, or document rework and evaluation of non-conforming finished devices or part.
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Venturi Ventilator, used to provide a software that continouslyadapts to the patient’s changing breathing demands and assures ventilation at the lowest pressure. The display monitor provides pertient patient parameters and waveforms. Recall #Z-802-9. REASON Display monitor may go blank due to faulty inverter. CODE Serial numbers: 970192, 970190, 970154, 970164, 970169, 970172, 970138, 970161, 970163,...
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Nikkiso Co. Ltd. 1/27/98 Hemodialyzers 2. Failure to validate computer software for its intended use according to an established protocol when software is used as part of production or the quality system, as required by 21 CFR 820.75(j). For example, the software used to perform _____ has not been validated. This software is part of...
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Witt Biomedical Corp. 1/23/98 Cardiac catherization monitoring system Failure to establish and maintain adequate procedures for changes to a specification, method, process, or procedure, e.g., software installation procedures are being changed without using an approved process pursuant to established procedures;
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Mennen Medical Ltd. 1/21/98 Patient Monitors c. The approval page for the Horizon 9000WS Cathlab’s software located in the document control department contained the signature of the originator of the document, but it lacked an approval signature. This approval page was different from the approval page for the same software located in the production department....
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Failure to document approval of all documents established to meet the requirements of part 820, including the date and signature of the individual(s) approving the document, as required by 21 CFR 820.40(a). For example, the device master record was not signed or dated to indicate approval, and the master and working copies of Software for...
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No evidence of validation of computer system or software; use of unrecognized testing methods for testing and release of finished products; and no review and approval by the Quality Control Unit of Oxygen USP and Nitrogen NF. 1. No documented evidence of the validation for the computer system or associated software that is responsible for...
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Failure to validate the finished device testing software for the ProNeb and Duraneb 2000 compressors and complaint handling software according to established protocols; failure to establish written procedures for monitoring and control of process parameters; failure to establish written procedures and to develop specifications for the contract manufacturer; and failure to establish final acceptance procedures....
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b. Changes made to the software program for the _____ have not been formally reviewed and approved by designated representatives of the firm…..Your response is not adequate because it does not include documentation showing formal review and approval of the software program changes. a. A user manual (or SOP) is not available for the _____...
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3) There are insufficient controls in place to ensure the integrity of calculated data generated by the _____ software in the Quality Control Laboratory, in that:.
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CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall#Z-369-9. REASON Software error causes 16 different assays to not calculate SI units correctly. CODE All lot numbers for ACS 180 SE Analyzers. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete. DISTRIBUTION...
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Failure to review, evaluate and investigate complaints involving the possible failure of a device to meet any of its performance specifications; failure to thoroughly evaluate and investigate complaints; and failure to validate software used in tracking and trending service and complaints. 4. Failure to validate software used in tracking and trending service and complaints. For...
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4) Failure to produce documented evidence to demonstrate the computer controlled/automated system for the manufacturing of liquid oxygen and nitrogen has been validated.
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The Food and Drug Administration (FDA) inspected your medical practice on September 3, 4 and 15, 1997, and determined that you are using an unapproved excimer laser system assembled by _____ an engineering consultant with _____ and representatives of _____ This laser system contains software developed by _____ with your input into its design. This...
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You failed to respond to calibration failures of the ultraviolet (UV)/visible spectrophotometer as required by your procedures. Instruments were not taken out of service, logbooks did not reflect passing/failing calibrations, certificates of calibrations were incomplete, there was no investigation into the cause of failures and no record was maintained of the corrective action taken as...
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Failure to establish and implement an adequate complaint handling system. Although the computerized complaint system used by your firm allows input from all departments, there is no system in place to assure that all service records are reviewed and evaluated for potential inclusion in the complaint handling system.
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We acknowledge that you have destroyed key components of the _____ and thus have terminated your _____ of this device. Please advise this office, in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent recurrence in future _____ of violations similar to those listed above....
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Failure to validate the heat sealing equipment; failure to validate the software in use to calculate GPL and MPL unit values; failure to provide adequate documentation to assure that the product will maintain its functionality throughout its labeled expiration date; and the quality assurance program failed to respond to device quality problems identified as a...
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1. Failure to validate major equipment used in the manufacture of medical devices (i.e. computer-driven Kiwa mills, Mori Seiki SL2B lathe, and Citizen lathes);
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Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria; failure to establish and maintain an adequate organization structure; and failure of the device master record to include, or refer to the location of, for each type of device, device...
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a) Failure to validate finished device testing software, some of which were incorrectly programmed. b) Test software failed to contain a test process/calculation to assure that finished device accuracy specifications were met. e) Failure to establish written and approved manufacturing procedures for finished device test software for MRX multi board and single board devices.
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9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.
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4. The HPLC computer software (_____, which is used for data acquisition, calculations, and system control, is not validated in that areas such as system operations, system maintenance, change control, data back-up and archival, system security and disaster recovery have not been evaluated.
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Your software system which is used to defer donors, does not flag subsequent donations of donors who previously tested positive for certain viral markers. Your procedure, “Computer Entry of Donor Deferrals”, describes four donor status codes (N-Normal, D-temporarily deferred, P-permanently deferred and R-permanently deferred allogenic donor but acceptable autologous donor). However, the software system interprets...
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In addition, there was no assurance that the dispensing pump delivers accurate doses. For example, daily accuracy tests on the pump were not documented and the _____ software, revision _____ was not validated to verify installation, operation, and performance.
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On May 8, 1996, you submitted an _____ for studies of _____ using an _____ (_____ hereafter “_____”). By letter dated June 7, 1996, (the _____ letter), FDA approved your _____ Under the _____ you may perform _____ to treat _____ for 300 patients at one institution. FDA also requested in the _____ approval letter...
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11. Failure 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)] in that there are no procedures for control of the software including procedures to control inappropriate or incorrect changes to the specifications...
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You have failed to appropriately validate the sterilization equipment and process in use. You could not provide documented evidence which established a high degree of assurance that the sterilizers and the sterilization process in use are effective and could consistently produce a product meeting its predetermined sterility specifications and quality attributes. You have failed to...
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Data management software systems …We are writing to you because on February 28 through March 3, 1997, Investigator James E. Moore from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the products known as the “_____” and the “_____” data management software systems, which are made and marketed...
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3. The software was changed, consistent with the new performance specifications. 2. Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example: a) The validations were not documented for the computer software used...
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3. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). This would also be a violation of the Quality System Regulation, 21 CFR 820.70(i). For example, no documentation of specific software changes, which were made to the _____...
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3. Failure to maintain written validation protocol and procedures for software and hardware maintenance for the _____ computer system version _____ . 4. Failure to have documented validation for the _____ software and the _____ software. Observation #12. Security controls should be established in writing. They should address the automated test system, as well as...
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