therelationship between values indicated by an instrument or system for measuring(especially weighing), recording and controlling, or the values represented bya material measure, and the corresponding known values of a reference standard.Limits for acceptance of the results of measuring should be establi...
2.3. Furthermore, as regulators request and review data and information such as the development data of products and processes, design of experiments, validation and stability results, it has become necessary to ensure that the facilities, quality systems, data and information meet the appropriate st...
An audit trail provides for a securerecording of life cycle details such as creation, additions, deletions oralterations of information in a record, either paper or electronic, withoutobscuring or overwriting the original record. An audit trail facilitates thereconstruction of the history of such even...
4.7. Results should be recorded, reviewed, analyzed and compared against the predetermined acceptance criteria. All critical and major test discrepancies that occurred during the verification/validation testing, should be investigated and if accepted they should be appropriately justified. 应记录、审核、分...
4.7. Results should be recorded, reviewed, analyzed and compared against the predetermined acceptance criteria. All critical and major test discrepancies that occurred during the verification/validation testing, should be investigated and if accepted they should be appropriately justified. ...
4.7. Results should be recorded, reviewed, analyzed and compared against the predetermined acceptance criteria. All critical and major test discrepancies that occurred during the verification/validation testing, should be investigated and if accepted they should be appropriately justified. ...
2.5. There are further risks associated with the production, validation, control, shipping, storage and use of investigational products. 对于试验用药品,存在着与生产、验证、控制、运输、存储和使用有关的其他风险。 2.6. To minimize risks and to ensure that the results of clinical trials are unaffected...
6.2. Full audit trails should be enabled from the time of installation of software.从软件安装...
2.2 The microbiological and chemical quality of water should be controlled throughout production, storage and distribution. While chemical test results can normally be obtained without delay, results from microbiological testing are normally available only after w ater has already been used as microbiologi...
referencestandard.Limitsforacceptanceoftheresultsofmeasuringshould be established. cleanarea.Anareawithdefinedenvironmentalcontrolofparticulate andmicrobialcontamination,constructedandusedinsuchawayastoreduce theintroduction,generation,andretentionofcontaminantswithinthearea. ...