Get your toughest Quality and Compliance problems solved by world renowned experts. Ask a question and get multiple answers from multiple experts and users and choose which one best solves your particular problem. Answer to questions posted by other users and earn points allocated.
The ComplianceOnline Answers
Email Address:
Password:

 Question:
Internal SOPs aside, when MUST a configuration change to an electronic QMS be captured in a Change Control? Question Id:6901
Deven roberts
08-05-2019 06:08AM
User Id: 186782
With Reference to Webinar - Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR (ID - 701687)
I understand that if I were to make a change that would put our electronic QMS out of a state verified/allowable/approved during the validation process into an UN-validated state, this would need to be captured in a Change Control. However, is there any regulatory standard/requirement that requires ALL changes of a certain type/types to be captured via change control? Or is acceptable to define and justify the risk for each change as QA?
Points for this question:10

  Upcoming Trainings  
Effective Vendor Risk Management
Instructor : Mario Mosse
Live Friday, October 11, 2019
11:00 AM PDT | 02:00 PM EDT


CMS Two Midnight Rule
Instructor : Bernadette Benta
Live Friday, October 11, 2019
10:00 AM PDT | 01:00 PM EDT


5 Tips to Engage Your Associates In Your Safety Program
Instructor : Michael Aust
Live Friday, October 11, 2019
10:30 AM PDT | 01:30 PM EDT


How To Implement An Effective Human Error Reduction Program
Instructor : Ginette M Collazo
Live Monday, October 14, 2019
10:00 AM PDT | 01:00 PM EDT


Best Sellers

Bankruptcy Law Update
Instructor : Mike Morley
OnDemand Access Anytime