20211111 Quality Quiz

優良文件規範遵循_____準則,並適用於文件的整個生命週期

Good Documentation Practices follow the _____ principles and are applied throughout the documents lifecycle

• ALCON

• ALCOC

• ALCOQ

• ALCOA

• ALCOG

Alcon Training system is

愛爾康使用的訓練系統為

• Vivity

• Veeeva

• Viva

• Plateau

• Veeva

Where can you find a currently effective version of GxP document form? E.g. complaint form 1.

請問哪裡可以取得現行生效的正確GxP文件表單? 如: complaint form 1.

• Plateau download

• Plateau Ezdoc.

• Veeva Source document

• 找QA Eddy

• Novartis Spectrum

What is the rating of Taiwan Global QMS and PV audit of year 2021?

請問台灣2021年的Global QMS以及PV的稽核結果為何?

• Great

• Good

• Needs improvement

• Satisfactory

• Excellent

In which tab can you find your personal training completion record?

請問您可以從哪個頁簽查找個人的Training完成紀錄?

• Plateau training completion

• Veeva All document

• Veeva Library

• Veeva training completion

• Veeva training assignment

Which is the AE/PC public reporting mailbox in Taiwan?

台灣區通報AE/PC的公共信箱為下列哪一個選項?

• [e-mail]

• [e-mail]

• [e-mail]

• [e-mail]

• [e-mail]

What is the required timeline for you to report an Pharma AE case?

Pharma AE的案件需要多久內通報

• 48小時

• 24小時

• 1個工作天

• 1個日曆天

• 2個工作天

Which is the dept./mailbox you should report to if you have a Medical Inquiry?

如果有Medical inquiry 應該通報下列哪一個單位/信箱?

• [e-mail]

• [e-mail]

• [e-mail]

• [e-mail]

• [e-mail]

Which is not the lifecycle of a Veeva document?

下列哪個不屬於Veeva的文件週期狀態?

• Reject

• Draft

• Approved

• Issued

• Superseded

優良文件規範的應用是為確保資料的___和___.

Good Documentation Practices are applied to ensure the ___ and ___ of data.

• Independence

  獨立性

• Accountability

  當責性

• Accessibility

  可使用性

• Integrity

  完全性

• Reliability

  可靠性