Retrospective Evaluation

The awareness for the need of GLP compliance in the development, and functional and operational testing of instruments increasingly equipped with 

In summary, for every computerised system which has not been validated in a proper, prospective manner, there should at least then exist documented justification available for its use, on the one hand in terms of historical records of proper functioning and on the other hand in terms of continued suitability ensured through the conduct of appropriate system tests. 

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RELEASE DATE PRODUCT NAME VERSION NUMBER 

THIS DOCUMENT CERTIFIES THAT THE ABOVE NOTED SOFTWARE PRODUCT/SYSTEM WAS DEVELOPED. TESTED AND VAUDATED ACCORDING TO THERMO SEPARATION ipucrs SOFTWARE DEVELOPMENT GUIDEUNES. THE MET ALL FUNCTIONAL AND PERFORMANCE IS AND PRODUCT RELEASE REQUIREMENTS. 

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Frazao C, C Topham, V Dhanaraj and T L Blundell 1994. Comparative Modelling of Human Rer Retrospective Evaluation of the Model with Respect to the X-ray Crystal Structure, Pure and A Chemistry 66 43-50. 

EPSRC 1999 Ri.sk As.ses.sment and Management - A Retrospective Evaluation of the EPSRC s Recent Research Portfolio. Swindon Engineering and Physical Sciences Research Council, UK. http //www.epsrc.ac.uk/... 

The evaluation function may be subdivided into retrospective evaluation of existing regulations and practices and prospective planning for new ones. Retrospective evaluation involves the following functions ... 

Meteorological services are closely related to both retrospective evaluation and prospective planning. The last two items on the proceeding two lists are the same. 

Kastrau et al. Stroke 2005 36(4) 825-829 Retrospective evaluation of aphasia in patients with hemicraniectomy for dominant sphere infarcts 14 patients with surgery evaluated with psychometric quantification twice over 470 days Evolution of aphasic symptoms 13/14 patients with improved scores and increased ability to communicate from baseline in 13 patients. Young age and early decompressive surgery were main... 

Develop policy-supporting SOPs on computer systems. These may include development, testing, maintenance and support, quality assurance, change control, source code management, system retirement, retrospective evaluation, evaluation of vendor-supplied systems, etc. 

Generate and maintain an inventory of all systems utilized by the organization, categorizing them as regulated and nonregulated systems. Identify prospective validation or retrospective evaluation needs for each system and record the current validation status. 

For existing systems, conduct a retrospective evaluation of historical versions. Document the adequacy of the historical documented evidence (historical and current versions) and any actions that will be taken to prove the validation stams of the system. 

Noli, C., Koeman, J.P., andWillemse, T., A retrospective evaluation of adverse reactions to trimethoprim-sulphonamide combinations in dogs and cats. Vet. Q., 17, 123-128, 1995. 

Prospectively and retrospectively evaluate, explain and extrapolate from the relationships between nonclinical trial findings and adverse clinical trial... 

Wong 0, Utidjian MD, Karten VS. 1979. Retrospective evaluation of reproductive performance of workers exposed to ethylene dibromide (EDB). J Occup Med 21 98-102. 

Lindquist M, Stahl M, Bate A, et al. A retrospective evaluation of data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Safety 2000 23 533 2. 

Lewis, D. F., Iannides, C., and Parke, D. V. (1995) A retrospective evaluation of COMPACT predictions of the outcome of NTP rodent carcinogenicity testing. 

Affective Group. Conventional TCAs have had a variable and sometimes lackluster effect on the depressive symptoms seen in BPD. Indeed, some studies indicate that these drugs may worsen symptoms, particularly by increasing irritability and agitation (238). By contrast. Cole et al. (239) did a retrospective evaluation of drug response in patients with BPD and major depression, noting that five of six who received TCAs responded, whereas BPD patients without depression treated with a TCA did not respond. 

In order to determine how useful the Presster would be in predicting the behavior of a formulation on a production tablet press, it was decided to do a retrospective evaluation of two products that are routinely manufactured in production. The conditions used for manufacturing the two products in production were simulated on the Presster and the results are presented in Figures 3 and 4. 

Hertzman, C., Teschke, K., Dimich-Ward, H. Ostry, A. (1988) Validity and reliability of a method for retrospective evaluation of chlorophenate exposure in the lumber industry. Am. J. ind. Med., 14, 703-713... 

All patients admitted to a hospital during 6 months who had taken at least one dose of metformin were retrospectively evaluated for susceptibility factors for metformin-associated lactic acidosis (8). There were 263 hospitalizations in 204 patients. In 71 admissions there was at least one contraindication, such as renal or liver disease, renal dysfunction, congestive cardiac failure, metabolic acidosis, or an intravenous iodinated contrast medium given within 48 hours of metformin. In 29 (41%) metformin was continued despite the contraindication. The most frequent contraindication was a raised serum creatinine, but in only eight of the 32 admissions was metformin withdrawn. Of nine patients using metformin who died (not necessarily directly related to metformin), six had an absolute contraindication. In two patients who died and in one who survived, blood lactate was increased and this was temporally related to the use of metformin. 

For existing computer systems, retrospective evaluation is discouraged. It is extremely difficult to evaluate a computer system retrospectively, being generally more costly and time consuming than prospective validation. Retrospective evaluation should be used only as a corrective measure in response to deficiencies noted concerning prior validation efforts. See Chapter 19 for a brief discussion on this subject. 

If evaluation results do not meet the current regulatory requirements, then the retrospective evaluation would not in itself support the trustworthiness of the electronic records. This is an area of concern for electronic records recorded using legacy systems after August 1997. 

Retrospective evaluation Establishing documented evidence that a system does what it purports to do, based on an analysis of historical information. The process of evaluating a computer system currently in operation against standard validation practices and procedures. The evaluation determines the reliability, accuracy, and completeness of a system. 

The differential diagnosis includes idiopathic torsion dystonia, parkinsonism, idiopathic torticollis, Huntington s disease, Wilson s disease, and Meige s syndrome (blepharospasm, oromandibular dystonia). A retrospective evaluation of the records of patients with idiopathic cervical dystonias (n = 82) and tardive cervical dystonias (n = 20) has been performed, in a search for clinical features that could help separate these closely related disorders (332). Despite the overall similarity, the presence of a dystonic head tremor was strongly suggestive of the idiopathic form, which was present in 42% and did not occur at all in the tardive group. A family history of dystonia (10%) was also exclusive to the idiopathic group. 

The following checkhst is based on work by the German APV for practitioners validating existing compnter systems that were not, or were only partially, developed in accordance with validation reqnirements. Some practitioners prefer to use the term retrospective evaluation to highlight that the exercise is founded on the principle of a comphance gap analysis and conseqnential remedial actions. It is important to realize that any retrospective vahdation takes more elTort than prospective validation and rarely achieves the same standard. 

Interestingly, compatibility within the blood group system has proved to be the decisive factor in liver transplantation to date. Although the HLA system is usually determined (for retrospective evaluation), it is of minor importance according to present knowledge. This is also true of so-called "cross-matching between... 

Spiller HA, Revohnski DH, Winter ML, Weber JA, Gorman SE. Multi-center retrospective evaluation of oral benzocaine exposure in children. Vet Hum Toxicol 2000 42(4) 228-31. 

Case reports and a retrospective evaluation of seven renal transplant patients showed that troglitazone can increase ciclosporin metabolism with a subsequent reduction of 15-45% in ciclosporin trough concentrations (299). The interaction of ciclosporin with troglitazone has been confirmed in four heart transplant patients with a 30-60% fall in ciclosporin concentrations within days of taking troglitazone 200 mg/day (300). 

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