| Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (Draft 3):PI 041-1.[EB/OL]. (2018-11-30)[2020-06-08]. https://picscheme.org/docview/2342 |
| The United States Pharmacopeial Convention. United States Pharmacopeia. Chapter <1058>. Analytical Instrument Qualification[EB/OL]. 2nd ed. (2019-01-31)[2020-06-08]. https://hmc.usp.org/system/files/general-chapters/GC-Pdfs_2019/_1058_%20ANALYTICAL%20INST-RUMENT%20QUALIFICATION.pdf |
| International Society for Pharmaceutical Engineering. GAMP® Good Practice Guide:A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems[EB/OL]. 2nd ed.[2020-06-08]. www.ispe.org |
| Active Pharmaceutical Ingredients Committee. Practical risk-based guide for managing data integrity[EB/OL]. 1st ed. (2019-03-01)[2020-06-07]. https://www.apic.cefic.org/pub/Data_Integrity_Best_Practices_Guide_for_API_FINAL_March-2019.pdf |
| 孟紫强. 现代环境毒理学[M]. 北京:中国环境科学出版社, 2015:12 Meng Z Q. Modern Environmental Toxicology[M]. Beijing:China Environmental Science Press, 2015:12(in Chinese) |
| 霍桂桃, 张曦, 吕建军, 等. 药物临床前安全评价机构计算机化系统的验证[J]. 药物评价研究, 2017, 40(11):1525-1530 Huo G T, Zhang X, Lv J J, et al. Validation of computerized system in facilities for preclinical safety evaluation of drugs[J]. Drug Evaluation Research, 2017, 40(11):1525-1530(in Chinese) |
| International Society for Pharmaceutical Engineering. GAMP® Guide:Records & Data Integrity[EB/OL]. (2017-03-01)[2020-06-08]. www.ISPE.org |
| McDowall R D. Data Integrity and Data Governance:Practical Implementation in Regulated Laboratories[M]. Surrey Croydon:CPI Group (UK) Ltd, 2019:330-331 |
| Burgess C, McDowall R D. An integrated risk assessment for analytical instruments and computerized laboratory systems[J]. Spectroscopy, 2013, 28(11):1-7 |
| Liscouski J. Computerized Systems in the Modern Laboratory:A Practical Guide[M]. PDA and Davis Healthcare International, 2015:4 |