ABSTRACT
In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.
ABSTRACT
Objective To investigate the association of single nucleotide polymorphism (SNP) in micro RNA-122 (miRNA-122) with genetic predisposition and early recurrence after resection for hepatocellular carcinoma(HCC).Methods This is a case-control study involving 173 HCC patients.DNA were exacted from cancer tissues embedded in paraffin and were amplified by PCR.The study aimed to explore SNP in gene sequence of miRNA-122 (357 base pair including extron.The outcomes of genetic predisposition were analyzed with early recurrence after resection for HCC.Results Only rs17669 was found in miRNA-122.The genetype frequence of C/C,T/T and C/T at rs17669 gene locus were 7(4.0％),110(63.6％)and 56(32.4％),respectively.When compared to T/T genetype,C/C genetype was a protective factor of risk of HCC (OR =0.213,95％ CI:0.062-0.732).Genetypes had no relationship with early recurrence after resection.Conclusion For HCC recurrence,rs17669 may be associated with genetic predisposition of HCC in Hans in Jiangxi infected with HBV.