title: ÐÐ½ÑÐ¾ÑÐ¼Ð°ÑÐ¸Ð¾Ð½Ð½Ð¾Ðµ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ðµ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¼Ð°Ð³Ð¸ÑÑÑÐ°
titleType: Subtitle
title: Information quality assurance of processes pharmaceutical development
Creators: name: ÐÐ²Ð´Ð¾ÐºÐ¸Ð¼Ð¾Ð²Ð°, ÐÐ½Ð½Ð°
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2023
Subjects: Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ðµ ÐºÐ°ÑÐµÑÑÐ²Ð°
ÐºÐ¾Ð¼Ð¿ÑÑÑÐµÑÐ¸Ð·Ð¸ÑÐ¾Ð²Ð°Ð½Ð½Ð°Ñ ÑÐ¸ÑÑÐµÐ¼Ð°
ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ°Ñ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ°
ÑÐµÐ»Ð¾ÑÑÐ½Ð¾ÑÑÑ Ð´Ð°Ð½Ð½ÑÑ
Ð¿ÑÐ¾ÑÐ»ÐµÐ¶Ð¸Ð²Ð°ÐµÐ¼Ð¾ÑÑÑ Ð´Ð°Ð½Ð½ÑÑ
Ð²Ð°Ð»Ð¸Ð´Ð°ÑÐ¸Ñ
quality assurance
computerized system
pharmaceutical development
data integrity
data traceability
validation

description: Ð¢ÐµÐ¼Ð° Ð²ÑÐ¿ÑÑÐºÐ½Ð¾Ð¹ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½ÑÐ¹ ÑÐ°Ð±Ð¾ÑÑ: Â«ÐÐ½ÑÐ¾ÑÐ¼Ð°ÑÐ¸Ð¾Ð½Ð½Ð¾Ðµ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ðµ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸Â». ÐÐ±ÑÐµÐºÑÐ¾Ð¼ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ Ð´Ð°Ð½Ð½Ð¾Ð¹ ÑÐ°Ð±Ð¾ÑÑ ÑÐ²Ð»ÑÐµÑÑÑ Ð¸Ð½ÑÐ¾ÑÐ¼Ð°ÑÐ¸Ð¾Ð½Ð½Ð¾Ðµ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ðµ (ÐÐ) ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð¸ ÑÐµÐ³Ð¸ÑÑÑÐ°ÑÐ¸Ð¸ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½ÑÑ ÑÑÐµÐ´ÑÑÐ² (ÐÐ¡). ÐÑÐ°ÐºÑÐ¸ÑÐµÑÐºÐ¾Ðµ ÑÐ°ÑÑÐ¼Ð¾ÑÑÐµÐ½Ð¸Ðµ Ð¾Ð±ÑÐµÐºÑÐ° Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð¾ Ð½Ð° Ð¿ÑÐ¸Ð¼ÐµÑÐµ ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸ ÐÐ Â«Ð¤Ð°ÑÐ¼ÐÐ¾Â». Ð¦ÐµÐ»ÑÑ Ð´Ð°Ð½Ð½Ð¾Ð³Ð¾ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐ²Ð»ÑÐµÑÑÑ Ð¿ÑÐ¾Ð°Ð½Ð°Ð»Ð¸Ð·Ð¸ÑÐ¾Ð²Ð°ÑÑ ÑÐµÐ¾ÑÐµÑÐ¸ÑÐµÑÐºÐ¸Ðµ Ð¸ Ð¿ÑÐ°ÐºÑÐ¸ÑÐµÑÐºÐ¸Ðµ Ð°ÑÐ¿ÐµÐºÑÑ ÐÐ Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð¸ ÑÐµÐ³Ð¸ÑÑÑÐ°ÑÐ¸Ð¸ ÐÐ¡, Ð¸ Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ Ð°Ð½Ð°Ð»Ð¸Ð·Ð° ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐ°ÑÑ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ñ Ð¿Ð¾ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ Ð´Ð»Ñ ÐÐ Â«Ð¤Ð°ÑÐ¼ÐÐ¾Â». ÐÐ»Ñ Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð¸Ñ ÑÐµÐ»ÐµÐ¹ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ñ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¸Ðµ Ð¸ ÑÐ¿ÑÐ°Ð²Ð»ÐµÐ½ÑÐµÑÐºÐ¸Ðµ Ð¼ÐµÑÐ¾Ð´Ð¾Ð»Ð¾Ð³Ð¸Ð¸, Ð° ÑÐ°ÐºÐ¶Ðµ Ð¸Ð½ÑÑÑÑÐ¼ÐµÐ½ÑÑ ÐºÐ²Ð°Ð»Ð¸Ð¼ÐµÑÑÐ¸Ð¸. ÐÐ»Ñ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ð¹ Ð¿Ð¾ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÐÐ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÐÐ Â«Ð¤Ð°ÑÐ¼ÐÐ¾Â» Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ñ ÑÐ»ÐµÐ´ÑÑÑÐ¸Ðµ Ð·Ð°Ð´Ð°ÑÐ¸: ÐÑÑÐ²Ð»ÐµÐ½Ñ Ð¿ÑÐ¾Ð±Ð»ÐµÐ¼Ñ ÐÐ; ÐÐ´ÐµÐ½ÑÐ¸ÑÐ¸ÑÐ¸ÑÐ¾Ð²Ð°Ð½Ñ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸Ñ Ðº ÐÐ; ÐÐ° Ð¾ÑÐ½Ð¾Ð²Ðµ ÑÑÐ°Ð²Ð½Ð¸ÑÐµÐ»ÑÐ½Ð¾Ð³Ð¾ Ð°Ð½Ð°Ð»Ð¸Ð·Ð° ÐÐ ÑÐ¾Ð³Ð»Ð°ÑÐ½Ð¾ Ð¸Ð´ÐµÐ½ÑÐ¸ÑÐ¸ÑÐ¸ÑÐ¾Ð²Ð°Ð½Ð½ÑÐ¼ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸ÑÐ¼ ÑÑÐ¾ÑÐ¼ÑÐ»Ð¸ÑÐ¾Ð²Ð°Ð½Ñ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ñ Ð¿Ð¾ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ; ÐÐ° Ð±Ð°Ð·Ðµ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ð¹ Ð¿Ð¾ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÐÐ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐ°Ð½Ñ Ð¼ÐµÑÐ¾Ð´Ñ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ ÑÐµÐ³Ð¸ÑÑÑÐ°ÑÐ¸Ð¸ ÐÐ¡, Ð² ÑÐ¾Ð¼ ÑÐ¸ÑÐ»Ðµ Ð¿Ð¾Ð´ÑÐ¾Ð´ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ»ÐµÐ¶Ð¸Ð²Ð°ÐµÐ¼Ð¾ÑÑÐ¸ Ð´Ð°Ð½Ð½ÑÑ. ÐÐ»Ñ Ð¿ÑÐ¾ÐµÐºÑÐ° Ð²Ð½ÐµÐ´ÑÐµÐ½Ð¸Ñ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ð¹ Ð¿Ð¾ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÐÐ Ð¿ÑÐ¸Ð²ÐµÐ´ÐµÐ½Ð¾ ÑÐµÑÐ½Ð¸ÐºÐ¾-ÑÐºÐ¾Ð½Ð¾Ð¼Ð¸ÑÐµÑÐºÐ¾Ðµ Ð¾Ð±Ð¾ÑÐ½Ð¾Ð²Ð°Ð½Ð¸Ðµ. Ð¡Ð¾Ð³Ð»Ð°ÑÐ½Ð¾ Ð¾ÑÐµÐ½ÐºÐµ ÐºÐ°ÑÐµÑÑÐ²ÐµÐ½Ð½ÑÑ Ð¸ ÐºÐ¾Ð»Ð¸ÑÐµÑÑÐ²ÐµÐ½Ð½ÑÑ Ð¿Ð¾ÐºÐ°Ð·Ð°ÑÐµÐ»ÐµÐ¹ ÐÐ Ð´Ð¾ Ð¸ Ð¿Ð¾ÑÐ»Ðµ Ð²Ð½ÐµÐ´ÑÐµÐ½Ð¸Ñ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ð¹, Ð¿ÑÐ¾ÐµÐºÑ Ð¿Ð¾Ð·Ð²Ð¾Ð»Ð¸Ð» Ð¿Ð¾Ð²ÑÑÐ¸ÑÑ ÐºÐ°ÑÐµÑÑÐ²Ð¾ ÐÐ Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² Ð½Ð° 63%, Ð¿Ð¾ÑÑÐ¾Ð¼Ñ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶ÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÐµÐºÑÐ° Ð¿Ð¾ Ð²Ð½ÐµÐ´ÑÐµÐ½Ð¸Ðµ ÐµÐ´Ð¸Ð½Ð¾Ð¹ Ð¸Ð½ÑÐ¾ÑÐ¼Ð°ÑÐ¸Ð¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð´Ð»Ñ Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð¸ ÑÐµÐ³Ð¸ÑÑÑÐ°ÑÐ¸Ð¸ ÐÐ¡, Ð° ÑÐ°ÐºÐ¶Ðµ Ð¿Ð¾Ð´ÑÐ¾Ð´ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ»ÐµÐ¶Ð¸Ð²Ð°ÐµÐ¼Ð¾ÑÑÐ¸ Ð´Ð°Ð½Ð½ÑÑ Ð¼Ð¾Ð³ÑÑ Ð±ÑÑÑ Ð¼Ð°ÑÑÑÐ°Ð±Ð¸ÑÐ¾Ð²Ð°Ð½Ñ Ð½Ð° Ð´ÑÑÐ³Ð¸Ðµ Ð¿ÑÐ¾ÑÐµÑÑÑ ÐÐ Â«Ð¤Ð°ÑÐ¼ÐÐ¾Â», Ð° ÑÐ°ÐºÐ¶Ðµ Ð½Ð° Ð¿ÑÐ¾ÑÐµÑÑÑ Ð´ÑÑÐ³Ð¸Ñ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¹ ÑÐ°ÑÐ¼Ð°ÑÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¾Ð¹ Ð¾ÑÑÐ°ÑÐ»Ð¸.
description: The subject of the graduate qualification work is Â«Information quality assurance of pharmaceutical development processesÂ». The object of the research of this work is the information assurance (IA) of the quality of the processes of pharmaceutical development and registration of medicines. The practical consideration of the object of the study was carried out on the example of the pharmaceutical company JSC "PharmCo". The purpose of this study is to analyze the theoretical and practical aspects of the IAÂ processes of pharmaceutical development and registration of medicines, and on the basis of the analysis to develop proposals for improvement for JSC "PharmCo". Analytical and managerial methodologies, as well as qualimetry tools, were used to fulfill the objectives of the study.In order to develop proposals for improving the quality control of the processes of JSC "PharmCo", the following tasks were performed: 1. IA problems identified; 2. Identified requirements for IA; 3. Based on the comparative analysis of the IA, according to the identified requirements, proposals for improvement are formulated; 4. On the basis of proposals for improving the IA, methods have been developed to ensure the quality of pharmaceutical drug registration development processes, including an approach to ensuring data traceability. A feasibility study is provided for the project of implementing proposals for improving the IA. According to the assessment of qualitative and quantitative indicators of IA before and after the implementation of the proposals, the project allowed to improve the quality of IA processes by 63%, therefore, the project proposals for the introduction of a unified information system for pharmaceutical development and drug registration processes, as well as the approach of ensuring data traceability can be scaled to other processes of JSC "PharmCo", as well as to the processes other pharmaceutical companies.