Lab Computer System Access and Backup

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1.0 Purpose 
 
 This procedure explains the access and backup of the computers located in the QC laboratory.
 
 2.0 Scope 
 
 This procedure is applicable to access and backup of the computers located in the QC
 laboratory that are designated for cGMP applications. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all personnel to access only the systems they are authorized to
 access and are currently qualified to operate (except for training purposes).
 
 3.2 Users are responsible for performing all duties under their own unique login and
 password. 
 
 3.3 It is the responsibility of QC Laboratory Management to implement this procedure and
 to ensure that the procedure is being followed. 
 
 3.4 It is the responsibility of QC Laboratory Management to keep this procedure aligned
 
 with current practices. 
 
 4.0 Definitions 
 
 4.1 QC — Quality Control 
 
 4.2 IT — Information Technology 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 QC Laboratory Computer System Access and Backup | D-815 5 Rage 2i0f3 
 
 5.0 References 
 
 5.1 21CFR Part 11, FDA Regulations on Electronic Records and Electronic Signatures
 
 6.0 Procedure 
 
 6.1 QC Laboratory Computer and Software Access 
 
 6.1.1 QC Laboratory computers and software accesses are restricted with the use of a
 
 unique username and password. 
 
 6.1.2 Only QC Laboratory Personnel, IT, and Quality Management are permitted to
 
 have accounts or log into QC Laboratory computers and instrument software.
 
 6.1.2.1 Access to all software and laboratory computers must be made through
 
 Quality Management and/or IT. 
 
 Only IT and QC Management have full access to computer software functions.
 
 6.1.3.1 General users will have limited functional access to equipment
 
 software. 
 
 6.1.4 Users are responsible for logging into the computer and/or software using their
 
 own unique username and password. 
 
 6.1.4.1 If two users are required to operate the same computer the second user
 
 can use the <switch user> function in the Windows menu to open a
 separate desktop. 
 
 6.1.4.2 Usernames and passwords are not to be shared. 
 
 6.2 Backup 
 
 6:2:1 The laboratory computers are configured by IT to backup any and all raw data
 created by the instrument or instrument software onto the company network
 
 server in timely intervals. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 QC Laboratory Computer System Access and Backup | D-815 5 | Page3 of3 
 
 6.2.2 IT will maintain all backups on the company network server. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/06/10 | New - - | - | - |
| 1 | 01/24/12 | Updated SOP z - | - | - |
| 2 | 03/07/13 | Updated SOP format, defined responsibilities | 13-126 | B. Johns |
| 3 | 02/19/15 | Biennial review. Updated SOP format. Changed Title. Updated software lists. Expanded responsibilities. 09/03/19 Scheduled review: Updated SOP to match current practices and 19-0618 L Garrett procedures. | 15-0178 | B. Johns |
| 5 | 04/04/23 | Scheduled review: updated format, logo, and responsibilities. CC- | 23-0188 | K. Burris |