title: Ð¡Ð¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ðµ ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð² Ð±Ð¸Ð¾ÑÐµÑ Ð½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð¹ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð±Ð°ÐºÐ°Ð»Ð°Ð²ÑÐ°
titleType: Subtitle
title: Improvement of the electronic quality management system in a biotechnology company
Creators: name: ÐÑÐ¾ÑÐ¸Ð½Ð°, ÐÐ°Ð»ÐµÑÐ¸Ñ
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: ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð°Ñ ÑÐ¸ÑÑÐµÐ¼Ð° Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð°
Ð±Ð¸Ð¾ÑÐµÑ Ð½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ°Ñ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ñ
Ð¿ÑÐ¾ÐµÐºÑ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ
ÑÐ¸ÑÑÐµÐ¼Ð½ÑÐ¹ Ð¿ÐµÑÐµÑ Ð¾Ð´
ECM-ÑÐ¸ÑÑÐµÐ¼Ñ
ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½ÑÐ¹ Ð´Ð¾ÐºÑÐ¼ÐµÐ½ÑÐ¾Ð¾Ð±Ð¾ÑÐ¾Ñ
electronic quality management system
biotechnology company
improvement project
system transition
ECM-systems
electronic documnet management

description: Ð¦ÐµÐ»ÑÑ ÑÐ°Ð±Ð¾ÑÑ ÑÐ²Ð»ÑÐµÑÑÑ Ð¿ÑÐ¾Ð¸Ð·Ð²ÐµÐ´ÐµÐ½Ð¸Ðµ Ð°Ð½Ð°Ð»Ð¸Ð·Ð° Ð¾ÑÐ½Ð¾Ð²Ð½ÑÑ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐµÐºÑÑÐµÐ¹ ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð² Ð±Ð¸Ð¾ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð¹ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸ Ð¸ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ° Ð¿ÑÐ¾ÐµÐºÑÐ° ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐ¡ÐÐ Ð² ÑÐ°Ð¼ÐºÐ°Ñ Ð¿ÐµÑÐµÑÐ¾Ð´Ð° Ð² Ð½Ð¾Ð²ÑÑ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ¾ÑÐ¿Ð¾ÑÐ°ÑÐ¸Ð²Ð½Ð¾Ð³Ð¾ ÐºÐ¾Ð½ÑÐµÐ½ÑÐ°. ÐÐ¾ÑÑÐ°Ð²Ð»ÐµÐ½Ñ Ð¸ ÑÐµÑÐµÐ½Ñ ÑÐ»ÐµÐ´ÑÑÑÐ¸Ðµ Ð·Ð°Ð´Ð°ÑÐ¸ ÑÐ°Ð±Ð¾ÑÑ: â¯ ÐÐ½Ð°Ð»Ð¸Ð· Ð´ÐµÑÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð±Ð¸Ð¾ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð¹ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸, ÐµÐµ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¼Ð¾Ð´ÐµÐ»Ñ Ð¸ ÑÐ¿ÐµÑÐ¸ÑÐ¸ÐºÑ Ð¾ÑÑÐ°ÑÐ»Ð¸ ÑÐµÐ°Ð»Ð¸Ð·Ð°ÑÐ¸Ð¸ Ð´ÐµÑÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸. â¯ ÐÐ¿ÑÐµÐ´ÐµÐ»ÐµÐ½Ð¸Ðµ Ð¿ÑÐµÐ´Ð¿Ð¾ÑÑÐ»Ð¾Ðº Ðº ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐ¡ÐÐ. â¯ ÐÐ½Ð°Ð»Ð¸Ð· ÑÐµÐºÑÑÐ¸Ñ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ¡ÐÐ. â¯ ÐÐ¾ÑÑÑÐ¾ÐµÐ½Ð¸Ðµ ÑÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð½ÑÑ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ¡ÐÐ Ð¸ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ° ÑÑÐ½ÐºÑÐ¸Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸Ð¹ Ðº ÑÐµÐ°Ð»Ð¸Ð·ÑÐµÐ¼Ð¾Ð¼Ñ Ð¼Ð¾Ð´ÑÐ»Ñ ECM-ÑÐ¸ÑÑÐµÐ¼Ñ. â¯ Ð Ð°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ° Ð¿ÑÐ¾ÐµÐºÑÐ° ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐ¡ÐÐ. â¯ ÐÑÐµÐ½ÐºÐ° ÑÑÑÐµÐºÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸ Ð¿ÑÐ¾ÐµÐºÑÐ°. Ð Ð°Ð±Ð¾ÑÐ° Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð° Ð½Ð° Ð¼Ð°ÑÐµÑÐ¸Ð°Ð»Ð°Ñ Ð¾ Ð´ÐµÑÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ ÑÐ°ÑÑÐ¼Ð°ÑÑÐ¸Ð²Ð°ÐµÐ¼Ð¾Ð¹ Ð±Ð¸Ð¾ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð¹ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸, ÑÐ¿ÐµÑÐ¸ÑÐ¸ÐºÐµ Ð¾ÑÑÐ°ÑÐ»Ð¸ Ð¸ Ð¾Ð¿ÑÑÐµ ÑÐµÐ°Ð»Ð¸Ð·Ð°ÑÐ¸Ð¸ ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð² Ð´ÑÑÐ³Ð¸Ñ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸ÑÑ. ÐÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð½ÑÐµ Ð¼ÐµÑÐ¾Ð´Ñ: Ð°ÑÑÐ¸ÑÐµÐºÑÑÑÐ½Ð¾Ðµ Ð¼Ð¾Ð´ÐµÐ»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ðµ, Ð¼Ð¾Ð´ÐµÐ»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ðµ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð², Ð¼ÐµÑÐ¾Ð´Ñ Ð¾ÑÐµÐ½ÐºÐ¸ ÑÑÑÐµÐºÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸ Ð¿ÑÐ¾ÐµÐºÑÐ¾Ð². Ð ÐµÐ·ÑÐ»ÑÑÐ°ÑÑ ÑÐ°Ð±Ð¾ÑÑ: â¯ Ð¡Ð¼Ð¾Ð´ÐµÐ»Ð¸ÑÐ¾Ð²Ð°Ð½ ÑÐµÐºÑÑÐ¸Ð¹ Ð¸ ÑÐµÐ»ÐµÐ²Ð¾Ð¹ ÑÐ¾Ð´ Ð¾ÑÐ½Ð¾Ð²Ð½ÑÑ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ñ Ð¿Ð¾Ð¼Ð¾ÑÑÑ Ð¿ÑÐ¾Ð³ÑÐ°Ð¼Ð¼Ð½Ð¾Ð³Ð¾ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Draw.io, Ð¾Ð±Ð¾ÑÐ½Ð¾Ð²Ð°Ð½Ð° Ð¿ÑÐ¸ÑÐ¸Ð½Ð° Ð¿ÐµÑÐµÑÐ¾Ð´Ð° Ðº ÑÐµÐ»ÐµÐ²Ð¾Ð¼Ñ Ð²ÐµÐ´ÐµÐ½Ð¸Ñ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² Ð² ÑÐ°Ð¼ÐºÐ°Ñ Ð¿ÑÐ¾ÐµÐºÑÐ° Ð¿ÐµÑÐµÑÐ¾Ð´Ð° Ð½Ð° Ð½Ð¾Ð²ÑÑ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ¾ÑÐ¿Ð¾ÑÐ°ÑÐ¸Ð²Ð½Ð¾Ð³Ð¾ ÐºÐ¾Ð½ÑÐµÐ½ÑÐ° ArchiMate, ÑÑÐ¾ÑÐ¼Ð¸ÑÐ¾Ð²Ð°Ð½Ñ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸Ñ Ðº Ð½ÐµÐ¾Ð±ÑÐ¾Ð´Ð¸Ð¼ÑÐ¼ Ðº Ð²Ð½ÐµÐ´ÑÐµÐ½Ð¸Ñ ÐÐ¢-ÑÐµÑÐµÐ½Ð¸ÑÐ¼. â¯ Ð¡Ð¾ÑÑÐ°Ð²Ð»ÐµÐ½Ñ ÑÑÐ½ÐºÑÐ¸Ð¾Ð½Ð°Ð»ÑÐ½ÑÐµ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸Ñ Ðº ÑÐµÐ»ÐµÐ²Ð¾Ð¼Ñ Ð¼Ð¾Ð´ÑÐ»Ñ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ¾ÑÐ¿Ð¾ÑÐ°ÑÐ¸Ð²Ð½Ð¾Ð³Ð¾ ÐºÐ¾Ð½ÑÐµÐ½ÑÐ° Ð´Ð»Ñ ÑÐµÐ°Ð»Ð¸Ð·Ð°ÑÐ¸Ð¸ ÑÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð½Ð¾Ð³Ð¾ Ð²ÐµÐ´ÐµÐ½Ð¸Ñ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð°. â¯ Ð Ð°Ð·ÑÐ°Ð±Ð¾ÑÐ°Ð½ Ð¿ÑÐ¾ÐµÐºÑ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¸ Ð¿Ð¾ÑÑÑÐ¾ÐµÐ½ Ð¿Ð»Ð°Ð½ ÑÐ°Ð±Ð¾Ñ Ð´Ð»Ñ ÑÐµÐ°Ð»Ð¸Ð·Ð°ÑÐ¸Ð¸. â¯ ÐÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð° Ð¾ÑÐµÐ½ÐºÐ° ÑÑÑÐµÐºÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸ Ð¾Ñ Ð²Ð½ÐµÐ´ÑÐµÐ½Ð¸Ñ Ñ Ð¿Ð¾Ð¼Ð¾ÑÑÑ Ð¿Ð°ÐºÐµÑÐ° MS Office. ÐÐºÑÑÐ°Ð»ÑÐ½Ð¾ÑÑÑ ÑÐµÐ¼Ñ ÑÐ°Ð±Ð¾ÑÑ Ð¾Ð±ÑÑÐ»Ð¾Ð²Ð»ÐµÐ½Ð° Ð½ÐµÐ¾Ð±ÑÐ¾Ð´Ð¸Ð¼Ð¾ÑÑÑ Ð¿ÐµÑÐµÐ½Ð¾ÑÐ° ÑÐ»ÐµÐºÑÑÐ¾Ð½Ð½Ð¾Ð¹ ÑÐ¸ÑÑÐµÐ¼Ñ Ð¼ÐµÐ½ÐµÐ´Ð¶Ð¼ÐµÐ½ÑÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð²Ð¾ Ð²Ð½ÐµÐ´ÑÐµÐ½Ð½ÑÑ ECM-ÑÐ¸ÑÑÐµÐ¼Ñ, ÑÐ¾Ð¾ÑÐ²ÐµÑÑÑÐ²ÑÑÑÑÑ ÑÑÐµÐ±Ð¾Ð²Ð°Ð½Ð¸ÑÐ¼ ÐºÐ¾Ð½ÑÑÑÐ° GxP, Ñ ÑÐµÐ»ÑÑ Ð²ÑÑÐ°Ð²Ð½Ð¸Ð²Ð°Ð½Ð¸Ñ ÐÐ¢-Ð»Ð°Ð½Ð´ÑÐ°ÑÑÐ° Ð¸ ÑÐ¾Ð²ÐµÑÑÐµÐ½ÑÑÐ²Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÐµÐºÑÑÐ¸Ñ Ð±Ð¸Ð·Ð½ÐµÑ-Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÑÐ¡ÐÐ, ÑÑÐ¾ Ð¿ÑÐ¸Ð²ÐµÐ´ÐµÑ Ðº ÑÐ¼ÐµÐ½ÑÑÐµÐ½Ð¸Ñ Ð²ÑÐµÐ¼ÐµÐ½Ð½ÑÑ Ð·Ð°ÑÑÐ°Ñ ÑÑÐ°ÑÑÐ½Ð¸ÐºÐ¾Ð² Ð¿ÑÐ¾ÑÐµÑÑÐ° Ð¸ Ð¿Ð¾Ð»Ð½Ð¾ÑÑÑÑ ÑÑÑÑÐ°Ð½Ð¸Ñ Ð½ÐµÐ¾Ð±ÑÐ¾Ð´Ð¸Ð¼Ð¾ÑÑÑ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸Ñ Ð±ÑÐ¼Ð°Ð¶Ð½ÑÑ Ð½Ð¾ÑÐ¸ÑÐµÐ»ÐµÐ¹ Ð´Ð»Ñ ÑÑÐ°Ð½ÐµÐ½Ð¸Ñ ÑÑÐ²ÐµÑÐ¶Ð´ÐµÐ½Ð½ÑÑ Ð´Ð¾ÐºÑÐ¼ÐµÐ½ÑÐ¾Ð² ÐºÐ°ÑÐµÑÑÐ²Ð°, ÑÑÐ¾ ÑÐ¾ÐºÑÐ°ÑÐ¸Ñ Ð·Ð°ÑÑÐ°ÑÑ ÐºÐ¾Ð¼Ð¿Ð°Ð½Ð¸Ð¸ Ð½Ð° Ð±ÑÐ¼Ð°Ð³Ñ Ð¸ ÐºÐ°Ð½ÑÐµÐ»ÑÑÐ¸Ñ. ÐÑÐ²Ð¾Ð´Ñ: ÐÐ°Ð´Ð°ÑÐ¸ ÐÐÐ  ÑÐµÑÐµÐ½Ñ, ÑÐµÐ»Ñ Ð´Ð¾ÑÑÐ¸Ð³Ð½ÑÑÐ°, Ð¿ÑÐ°ÐºÑÐ¸ÑÐµÑÐºÐ¾Ðµ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ ÑÐµÐ·ÑÐ»ÑÑÐ°ÑÐ¾Ð² ÑÐ°Ð±Ð¾ÑÑ ÑÐµÐ°Ð»Ð¸Ð·Ð¾Ð²Ð°Ð½Ð¾.
description: The aim of the work is to analyze the main business processes of the current electronic quality management system in a biotechnology company and develop a project to improve the eQMS as part of the transition to a new corporate content management system. The following work tasks have been set and solved: â¯ Analysis of the activities of a biotechnology company, its business model and the specifics of the industry in which activities are carried out. â¯ Determining the prerequisites for improving the eQMS. â¯ Analysis of current eQMS business processes. â¯ Construction of improved eQMS business processes and development of functional requirements for the implemented module of the ECM system. â¯ Development of a project to improve the eQMS. â¯ Evaluation of the effectiveness of the project. â¯ The work is based on materials about the activities of the biotechnology company in question, the specifics of the industry and the experience of implementing an electronic quality management system in other companies. â¯ Methods used: architectural modeling, business process modeling, methods for evaluating the effectiveness of projects. Results of work: â¯ The current and target course of the main business processes of the electronic quality management system was modeled using the Draw.io software, the reason for the transition to targeted business process management as part of the project for the transition to the new ArchiMate corporate content management system was substantiated, and the requirements for the necessary IT implementation were formed -solutions. â¯ Functional requirements for the target module of the corporate content management system for the implementation of improved business process management of the electronic quality management system have been compiled. â¯ A project for improving the electronic quality management system has been developed and a work plan has been drawn up for implementation. â¯ Evaluation of the effectiveness of the implementation using the MS Office package. The relevance of the topic of the work is due to the need to transfer the electronic quality management system to the implemented ECM system that meets the requirements of the GxP circuit in order to level the IT landscape and improve the current eQMS business processes, which will lead to a reduction in the time costs of process participants and completely eliminate the need the use of paper media for storing approved quality documents, which will reduce the companys costs for paper and stationery. Conclusions. The tasks of the WRC have been solved, the goal has been achieved, the practical application of the results of the work has been implemented.