1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Network server validation - Record Retention

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Sidney, Apr 5, 2017.

  1. Sidney

    Sidney New Member

    Joined:
    Apr 5, 2017
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    I am looking to move away from keeping hard copy files of policies, procedures, and forms by using a network server. My plan is to store documents within a folder in the the server. My question is does this need to be validated? Thanks.
     
  2. yodon

    yodon Active Member

    Joined:
    Aug 3, 2015
    Messages:
    77
    Likes Received:
    33
    Trophy Points:
    17
    Part 11 just says:

    (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

    So you do need to ensure whatever you set up does still meet the requirements.

    While there may not be an application to validate, it would at least be a good idea to walk through the requirements and describe how each is met. There may be some validation work in there to properly demonstrate. For example, how would you show:

    (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
     
  3. Micheli Lermen

    Micheli Lermen New Member

    Joined:
    Apr 24, 2018
    Messages:
    4
    Likes Received:
    1
    Trophy Points:
    2
    I think it 'll be good if you do an FMEA and describe how do you control who has access to change and edit files inside this folder, use strong passoword in your server and document the procedures of backup and the visibility that you have if someone changes something....
     

Share This Page