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Walter Graphtek Germany 7/1/96 EEG devices 3. Failure to perform planned and periodic audits in accordance with written procedures by appropriately trained individuals not having direct responsibility for the matters being audited, as required by 21 CFR 820.20(b). For example, the following areas were identified as having not been audited under your internal quality assurance...
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FDA CDRH Office of Device Evaluation’s “Draft Guidance for Implantable Cardioverter-Defibrillators Version 4.2” June 19, 1994. Section II.B addresses this so for documentation requirements for 510(k) submissions for this type of medical device by simply referring to the general software submission guidance and the Off-the-shelf software Submission guidance. Earlier versions of this draft at additional...
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GE Medical 6/16/96 X-Ray France 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, the software control processes have not been validated to correct the most serious faults. Failure to subject any...
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CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9. REASON Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements. CODE All serial numbers for the ACS...
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Somerset Medical Center Blood Bank 5/29/96 1. The validation of the Meditech Computer System is incomplete and/or inadequate for the following reasons: a. Computer documentation did not include testing procedures, system requirements, and system specifications which were specified to Somerset Medical Center. b. There is no assurance that all program changes resulting from the software...
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Planmed OY 5/9/96 Finland 3. Failure to routinely calibrate measurement equipment, to establish adequate calibration procedures, and to maintain records of calibration, including the next calibration date; and 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...
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Cobe 4/16/96 Hemodialysis 10. Failure to have adequate checks designed and implemented to prevent inaccurate data output, input, and programming errors when automated data processing is used for manufacturing or quality assurance purposes, as required by 21 CFR 820.195. For example, the computer search process for complaints by serial number is not designed to detect...
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Abaxis 4/5/96 blood analyzer 1. Failure to validate computer software programs by adequately documented testing, when computers are used as part of an automated production or quality assurance system (21 CFR 820.61). The computer programs which control the automated assembly of rotor parts, loading of reagent beads, dispensing of reagent beads into proper cuvettes, and...
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Barton Carey Medical Products 4/3/96 our Investigator determined that your firm manufactures vascular and burn compression garments. These garments are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The Inspection revealed that your devices are adulterated in that, the methods used in, or the facilities or controls...
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PIE Medical Equipment 4/1/96 Netherlands ultrasound 1. Failure to maintain records documenting that production and quality assurance measurement equipment is routinely calibrated, inspected, and checked according to written procedures and 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...
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Cabrini Medical Center Blood Bank 2/8/96 14. Failure to maintain written standard operating procedures for the blood bank’s computer system that include: integration of the computer into daily operations; reverting to manual operations when the system is not functioning; control of changes in hardware and software; security procedures to prevent unauthorized access; and maintenance procedures...
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McGHAN Medical Corporation 2/16/96 mammary prostheses The validation of the computerized dip timer system for software version [purged word] and [purged word] fails to assure that the previous files are overwritten when the maximum number of files [purged word] is reached. This is demonstrated by the fact that there was no verification of the file...
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2/14/96 ADAC Laboratories Pinnacle Radiation Therapy Planning Software 83 tapes recalled Due to a software problem, the wedge scatter fields will be calculated incorrectly if the wedge filter is not square. Software version 2.1F
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Ionetics 1/29/96 electrolyte analyzers 1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.
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“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store...
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http://www.fda.gov/cdrh/comp/guidance/fod456.pdf
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The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in...
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