Use of password managers on validated computer systems (21 CFR Part 11)

#1
What methods are companies using to restrict the use of password managers on validated computer systems to remain compliant to Part 11? I'm interested particularly in those that are accessed through an internet browser.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Interesting question, glad you posted! And welcome to the Cove.

Are you talking about something like KeePass that allows you to store passwords encrypted (and require a separate password to access) and copy/paste into the application or are you talking about field auto-fill from the browser?

In the former case, I'm not sure if it would be possible. And I'm not sure if it would be an issue, anyway. The users are still applying the credentials necessary even though it may be facilitated with another tool. Maybe I'm missing it, but what's the concern?

In the latter case, I'm pretty sure there are ways to restrict capture / storage of the field content (pretty common on sites where you enter a credit card number, for example).
 

Mark Meer

Trusted Information Resource
#3
...The users are still applying the credentials necessary even though it may be facilitated with another tool. Maybe I'm missing it, but what's the concern?...
I agree with yodon here. First, that this is an interesting question. Second, with respect to 21 CFR Part 11, what are your concerns with respect to non-compliance?

21 CFR Part 11 aside, however, there are certainly some practical considerations worth thinking about such as:
- Is this an all-eggs-in-one-basket case? Worst case, is there a recovery contingency if the master password was forgotten?
- (as pointed out by yodon) Do people allow browsers to automatically save and auto-fill password fields?
 
Thread starter Similar threads Forum Replies Date
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
Marc Latest Password Breaches - January 2019 World News 5
Scott Catron Stupid Password Tricks Coffee Break and Water Cooler Discussions 41
D SQL Server Username and Password Excel .xls Spreadsheet Templates and Tools 3
P HIPAA Privacy - Login password or USB Access key? Other US Medical Device Regulations 3
I 21 CFR PART 11 Password and User Name Requirements Software Quality Assurance 3
S Read Only & Password Protected - Sufficient to Control Documents under 4.2.3? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M The definition of the word Invalid as in "Password Invalid" Coffee Break and Water Cooler Discussions 7
optomist1 How to Delete a Powerpoint File Password After Work and Weekend Discussion Topics 3
Q 21 CFR Part 11 Password Requirement for a Web Service Software Quality Assurance 6
B Does anyone know if there is a way to password protect a folder? After Work and Weekend Discussion Topics 2
Richard Regalado Information Security Joke on Password Management Funny Stuff - Jokes and Humour 4
K Can a document approval be in the form of password? Document Control Systems, Procedures, Forms and Templates 22
N Quality Records - Password and Anti-virus Protection Records and Data - Quality, Legal and Other Evidence 3
kedarg6500 Protection of Records in soft copies - Password needed? Records and Data - Quality, Legal and Other Evidence 4
V Control of Forms - Do the blank forms need to be Password Protected? Document Control Systems, Procedures, Forms and Templates 19
F Is self-serve password reset for Windows considered for validation under CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 2
V SPC XL 2000 add-in for Excel.xls - Password Excel .xls Spreadsheet Templates and Tools 6
Marc Attribute Gage R&R Spreadsheet - Needs Password Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
C Ford Q1 Assessment Spreadsheet password Customer and Company Specific Requirements 3
M Informational Interesting read for risk managers – The Psychology of Prediction Medical Device and FDA Regulations and Standards News 1
G Example of Calibration Due Reminders to Leads, Managers & Directors General Measurement Device and Calibration Topics 3
J Root Cause Determination Training for Production Managers Nonconformance and Corrective Action 6
L Advice and Tips for my first Managers Meeting Quality Manager and Management Related Issues 8
N Engineers and Managers (joke) Funny Stuff - Jokes and Humour 4
K Interested in Interviewing Quality Managers for a Paperless Project Lean in Manufacturing and Service Industries 9
R Reorganization - Some New Employees were placed as Managers over some Owners Quality Manager and Management Related Issues 7
somashekar EXAM for Energy Managers and Energy Auditors (INDIA) Miscellaneous Environmental Standards and EMS Related Discussions 2
K Should project managers know what basic regulatory requirements are? Internal Auditing 17
T What our managers can learn from Jim Harbaugh (NFL Coach of the Year)? Coffee Break and Water Cooler Discussions 1
S Auditing Career: Dealing with Mentally Unstable Managers Career and Occupation Discussions 7
K The role of mid level managers in a Quality System Manufacturing and Related Processes 9
K Quality Responsibilities (job description) of Line Managers Misc. Quality Assurance and Business Systems Related Topics 8
N Management Review - Reports from Managers and Supervisors Management Review Meetings and related Processes 8
R Career advice for would-be Quality Managers Career and Occupation Discussions 12
D How can Leaders (Managers) encourage Team Work? Quality Manager and Management Related Issues 17
C Temporary employment agencies for temporary quality engineers and/or quality managers Career and Occupation Discussions 3
Sidney Vianna ISO advises managers how to get the best out of the ISO 9000 family ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I The Role of Managers and Employees deployment of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Jim Wynne Using Famous Quotations to Describe Bad Managers Coffee Break and Water Cooler Discussions 10
J Link to a vitual MBA Managers skills course pdf file Book, Video, Blog and Web Site Reviews and Recommendations 0
E Conflict? 2 Technical Managers identified (one for EMC, one for Reliability) ISO17025 ISO 17025 related Discussions 8
Ajit Basrur GMP training - New employees which includes Operators, Supervisors, Managers etc. Training - Internal, External, Online and Distance Learning 5
Jim Wynne A tale of two (bad) managers The Reading Room 20
Marc It's not just automotive - Verizon to Halt Pension Money for Its Managers World News 0
W For All QA Managers - The Spoon and the String Funny Stuff - Jokes and Humour 2
Z Rules of an audit interview - Writing a Cheat Sheet for Managers General Auditing Discussions 11
W Responsibility Matrix - Showing managers what their Responsibilities are Misc. Quality Assurance and Business Systems Related Topics 11
C Parents as System Managers Coffee Break and Water Cooler Discussions 15
R Internal Auditors - Managers not participating in the program Internal Auditing 6
Similar threads


















































Top Bottom