SOP of Computerized System User Management, Backup and Restoration

 Purpose :- This SOP Purpose for User Management, Data Back and Restoration of Manufacturing Computerised System.

Scope :- This SOP Shall be Applicable for Manufacturing / Quality System Computerized System.

Responsibility :- Information Technology/Engineering Department

Accountability :-  Respective Department Head

Procedure :- 

User Management 

Password Policy

A. Each user Should be Unique.

B. User name and Password Should be Unique.

C. Password shall have at least 8 Characters.

D. System shall not Acquire last 3 Expired Password.

E. Password Shall meet the complex password requirement which includes combination of upper /lower case alphabet numerical and non-alphanumeric/Alphabetic character (e.g. $#@!^&*).

F. Password validity shall be 60 days.

G. System shall be lockout automatically after 5 wrong login attempts.

H. Lockout of user shall be unlocked only by Administrator.

I. Display and printing of password should be masked so as unauthorized person can not observe it.

User Management Policyfour User Group Different Level of User (I.e. Administrator, Operator, Supervisor, Maintenance) and following are the Privilege group in Assigned Different different Privileges.

A. Administrator :- IT and Engineering or Respective Designee shall be the member of the Group.the member of this group has maximum rights and also have rights to assign the privilege to the other privilege group.Create/ Delete/Modify User.

B. Operator:-  the Person Responsible for the generation of histogram shall be the member of this Group . User Shall have rights e.g. Operation , Measurement, set Parameter , Reference Result , Print Report Etc. 

C. Supervisor :- In charge Manufacturing/QC Designee shall be member of the group. the member of the group shall have rights e.g. Edit Method File, Create and Edit custom calculations,view audit trail, Set Parameter edit and delete, Create and Modify Recipe etc.

D. Maintenance :-Engineering Person shall be Responsible for this user group. this user shall have rights of Engineering related activity. 

Data Backup 

1. Prepare the Computerised System List with Manufacturing/ Quality System.

2. Mention the List in Following Contain System name, IP Address, Equipment name, Equipment id,System Category etc.

3. Prepare the backup Schedule Plan (Yeary and Half yearly)

4. Tolerance of the yearly Back up +/- 15 days

5. Tolerance of the half yearly Backup +/- 7 days

6. Necessary Entry shall be made in Yearly and Half yearly Back up.

7. All the Back up store in Server/Taps in Fireproof Cabinet.

Storage and Removal backup data

1. The intermediate backup data shall be stored on IT Server up to completion of the system back up in Desired folder.

2. Monthly back up data shall be stored on IT Server up to Completion of the year.

3. Stored back up Removed in Server 3 year

Retrieval of back up data 

1. Restore from a back up copy note :- If you are testing a back up for the first time, we recommend restoring the back up in a test environment first (e.g. on a stadalone work station or isolated server). this way , if the back up is bed , restoring to it won't not affect your live data.

2. Verify user can log into the data base and that thye correct data is present .

3. Restore the original Data.

4. Retrieval of bake up or Archive electronic files shall be authorised by Quality Head/Designee.

5. Restore the data from backed -up tapes to IT Server and from IT server copy it to its original destination.