Hologics diagnostic solutions division moves to narrow the gap between doubt and confidence and works to achieve both incremental and transformative progress to improve patients lives. As expected, they came through with their usual responsiveness, innovation, pragmatism, and attention to detail. Therefore, hplc is taken as an example system for validation. The system includes protocol 3 software for colony counting, zone measurements inhibition zones and ast, membranes and petrifilm tm plates. It is handled by the instrument robotic arm to retrieve it and store it and it is operated by the system software. Disk imaging specs digital data acquisition tool test assertions and test plan draft 1 of version 1.
Product evaluation group responsible for all system software verification and validation. Implementation of the thinprep imaging system in a highvolume. However, tis may also influence the interpretation of pap tests, leading to changes in the frequency of various interpretive categories. Nov 19, 2015 hologic launches thinprep 5000 processor hologic, inc. Jul 06, 2018 a software program intended to be used with an in vitro diagnostic instrumentanalyser e. The validation process begins with the system proposalrequirements definition and continues until system retirement and retention of the erecords based on. Anthony catalano director software quality assurance. To date, thinprep has become the most widely used pap test. Hologics thinprep integrated imager receives ce marking approval. The cytyc corporation thinprep imaging system tis, a computer imaging based technology, is one of the recent devices introduced to assist in primary cervical screening of thinprep test slides for the presence of epithelial cell abnormalities as defined by the 2001 bethesda system for reporting cervical cytology tbs1,2.
Computer system validation protocol can be written in following steps. It can be installed onto the pc which is connected to the protocol via usb. Thin prep imaging system id worked with oti on previous projects, so i called them again when we needed optical engineering support on the cytyc project. Different biomedical scientists bmss, working on each procedure in rotation, performed batches of tisassisted. Balancing technology, planning, and compliance by david a. Hologic launches thinprep 5000 processor imaging technology. Verification slide is loaded when the processor is installed in the laboratory and is. Our implementation protocol included each cytotechnologist manually.
The positive impact of simultaneous implementation of the. This software verification and validation procedure provides the action steps for the tank waste information network system twins testing process. The thinprep imaging system combines the power of computerassisted screening with human diagnostic experience. However, this analysis software has limitations since other image analysis software is capable of showing each individual unmixed tsa fluorochrome with a positive signal without noise or. Design specification only for systems or areas of the system which contain custom code such as integrations between your product lifecycle management plm and enterprise resource planning erp systems. All surepath slides were evaluated using fpgs according to the manufacturers recommended protocol. The outcome of the vra can drive a split in software validation documentation scope, if the vra categorizes the software validation as requiring full life cycle validation flcv, then a considerable amount of the software validation effort is put into establishing how the software was designed and developed, in order to establish that its basic concept and development can be considered robust. Protocol 1 is preloaded with the thinprep stain protocol for customer convenience. The primary objective of the testing process is to provide assurance that the software. Application of the thinprep imaging system in urine. The oq design study identifies the range of kpiv variables which produces product which meets predetermined acceptable specifications. A clinical trial of the thinprep imaging system established at least equivalent. Tableofcontents 3dprojection 73 imageinfo 74 displayingmultichannelimages 76 multichannelviewsettings 77 changelayout 78 splittingmultichannelimages 82. Approval of the thinprep integrated imager brings the benefits of thinprep automated pap imaging to small and midsized laboratories in the united states, and of course to their patients.
Takes high magnification frames at more than 500 xy locations covering entire cell spot. Fda approval of thinprep integrated imager expands automated. Clinical validation of high risk hpv dna testing versus. The thinprep imaging system is a unique, cuttingedge computerised analysis system used in many australian pathology laboratories. The verification slide is stored inside the imaging. The positive impact of simultaneous implementation of. The cytyc thinprep imaging system received approval from the food and drug administration in june 2003 based, in part, on the results of a multiinstitutional clini. Validation of multiplex immunofluorescence panels using. Following completion of the thinprep imaging system validation protocol. Also able to be used as a conventional microscope, the thinprep integrated imager consolidates the needs of the cytotechnologist into one device. With a smaller footprint, the compass stainer is perfect for low volume imaging labs using the integrated imager, or. Product evaluation group responsible for all system software verification and validation activities in the cytological, prenatal and molecular diagnostics division of hologic corp.
Bernazzani both from intertech engineering associates, inc. Senior researcher, laboratory manager copenhagen university hospital, denmark. Protocol 3 software is complete with setup and calibration installation instructions. The positive impact of simultaneous implementation of the bd. Test protocols should be approved before protocol execution. The unexecuted protocol should be approved by the system owner and quality assurance.
Full validation of the computerized system is required for systems. Thinprep imaging system package insertsifus hologic. Both the thinprep and the fpgs are locationguided imaging systems that are approved for use with thinprep hologic inc and surepath preparations, respectively. Becton dickinson focalpoint gs imaging system american. Hosts system application software and system database. Effectiveness of the thinprep imaging system gynekolog.
The thinprep imaging system american cancer society journals. Page 17 following initial fda approval of the thinprep system, hologic conducted a multisite directtovial clinical study to evaluate the thinprep 2000 system versus conventional pap smear for the. Same trusted algorithm as the thinprep image processor, but with a faster camera, expanded labelreading formats and ondemand imaging. Then, the 1996 launch of the hologic thinprep pap test propelled screening success to new heights. The iq and oq reports resulting from execution of the protocol will provide an important component of a complete computer system validation compliance package. Detection of abnormal cervicovaginal cytology specimens. Thinprep imaging system implementation lead to a significant decrease in ppv for.
Protocol 3 automatic colony counting and zone measuring. Computerized system validation csv is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. Thinprep imaging system image processor operators manual. Hologic wins fda pma for thinprep automated pap test. After the validation of fpgs and the completion of cytotechnologist training, the 2 fpgs imaging systems were put into clinical use in june 2009. The primary procedure for screening conventional pap smear and. Clinical validation of high risk hpv dna testing versus thinprep cytology for primary cervical cancer screening. A software program intended to be used with an in vitro diagnostic instrumentanalyser e. Page 159 perating nstructions required slide label format for use with the thinprep imaging system for thinprep pap test slides that will subsequently be imaged by the thinprep imaging system, slide labels must be in an ocr, 14 character, 7 digitsover7 digits format, with the last 3 digits being a crc number. Thinprep imager duo imaging system operators manual. The iq and oq reports resulting from execution of the protocol will provide an important component of a complete computer system validation. Introduced in the 1940s, pap testing has been the single greatest contributor to the overall decline in cervical cancer. Installation qualificationoperational qualification.
Software analyzes images of cell spot, identifies objects of interest based on optical density. The oq qualification should be written in accordance with the validation. Validation, verification and testing plan authorization memorandum. The primary objective of the testing process is to provide assurance that the software functions as intended, and meets the requirements specified by the client. Hologic thinprep 2000 operators manual pdf download. In this weeks devicetalks weekly, well examine how governmental effort, both foreign and domestic, are hitting the medtech industry. The root causes derived from past investigations of reported abnormal cells not present in the 22 fovs fall mainly into two categories.
Statistical analysis was done using statistical package for social sciences software. It is designed to pinpoint potentially abnormal cells on a thinprep. The spreadsheet and associated excelsafe software will reside on the ofni systems. One important result of a software validation is that the software design or implementation code may have to be changed. Nucleoview software acquire, view, compare and export. Cases rescreened in the 10% random quality control qc program from the. Manuals, software information, and webinars are also listed. Can we change the way we screen the thinprep imaging system. New horizons in cervical cancer screening combining molecular and cytology based technologies to provide a solution for future of cervical screening jesper bonde, phd, dipl.
Our guests include tracy eberly, ceo of fang consulting. Validation, verification, and testing plan template. Evaluation of cellsolutions bestprep automated thinlayer. Several studies 1 9 have demonstrated that diagnostic performances of the thinprep imaging system. Medical device software validation validation and verification from a quality perspective. A comparison of thinprep imagerassisted with manual screening.
Two types of patient groups were enrolled in the trial from ten. Software validation protocol how is software validation. Validation of hplc system is most critical and important because all regulatory authorities focus on this instrument and different data integrity issues are found during fda inspections. The imaging agent route of injection is an extremely important consideration when imaging fluorescence. Validation of accuracy of the thinprep imaging system to identify abnormalities. Hologic thinprep 5000 operators manual pdf download. Aug 06, 2009 published reports have demonstrated that introduction of the thinprep imaging system imager to the cytology screening services has increased the detection rate of highgrade squamous intraepithelial lesions hsils. Apr 25, 2018 approval of the thinprep integrated imager brings the benefits of thinprep automated pap imaging to small and midsized laboratories in the united states, and of course to their patients, said. The blood establishment bears the responsibility for the regulatory compliance of the automated. A copy of the unexecuted protocol should be kept in the validation package. In general, nir imaging agents are designed for intravenous injection and are not optimized for injections by any other routes e. Hologic released the first fdaapproved, liquidbased cytology option in cervical disease screening in 1996. The nucleoview software automatically acquires and performs image analysis to detect nuclei. Subtle methodological differences between the trials may account for some of the data noted.
This testing protocol typically uses a statisical software package such as minitab to determine process capabilities. Thinprep imaging system tisassisted screening and routine. Following completion of the thinprep imaging system validation protocol, all imaged thinprep pap test results were tracked and compared with year2003 manually screened results to identify whether. Director software quality assurance manager hologic december 2004 present 14 years 11 months. Sep 30, 2009 please use one of the following formats to cite this article in your essay, paper or report. Odyssey clx application and technical notes show the versatility of the clx. The clinical trial carried out between december 2000 and november 2001 prior to approval demonstrated that the efficiency of the instrument was at least equivalent to the manual screening in all bethesda system. Svp is defined as software validation protocol somewhat frequently.
It is designed to pinpoint potentially abnormal cells on a thinprep pap test slide. Odyssey clx manuals, application notes, software, and webinars. Risk analysis the gamp standard template is recommended. Pdf introduction of the thin prep imaging system tis. Poorly designed or improperly executed validation studies negate the value of validation, providing the manufacturer with little or no benefit.
The thinprep 5000 autoloader system maximizes laboratory efficiency while offering even more walkaway freedom with up to 8 hours of handsfree processing of thinprep pap test, thinprep nongyn and thinprep urocyte samples. Cytological interpretations for thinprep pap tests were compared. Does the thinprep imaging system increase the detection of. The purpose of this performance qualification protocol is to define the requirements and acceptance criteria for the performance of the example validation spreadsheet. A comparison between locationguided thinprep imaging system tis and manual screening of thin prep samples tp acta cytol. This guidance outlines general validation principles that the food and drug administration fda considers to be applicable to the validation of medical device software or the validation of. Pdf use of the thinprep imaging system for internal quality. Imaging system is intended to help a cytotechnologist. Application of the thinprep imaging system in urine cytology. Identifies 22 areas of interest within the thinprep pap test slides with the largest, darkest nuclei for cytotechnologists to examine. Protocol acceptance by customer and list of tests performed biorad laboratories recommends that the iqoq protocols be performed in total when the experion automated electrophoresis station and software. Validation documents and results of tests performed by of the software be can the supplier incorporated into the omcls validation file and does not need tobe repeated again by the omcl. The cytyc thinprep imaging system was fda approved based.
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