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SOP for Software Validation

Standard operating procedure to validate the software of the instruments used in quality control laboratory like GC, HPLC, UV Spectrophotometer etc.
1.0 OBJECTIVE
To provide a procedure for software validation of HPLC and GC instruments.
2.0 SCOPE
This procedure is applicable for the software of HPLC and GC instruments used in the manufacturing facility.
3.0 RESPONSIBILITY
3.1 Executive / Designee from Analytical Research Department or Support Engineer: To perform Software Validation.
3.2 Executive / Designee from Analytical Research Department: To prepare a Software Validation Protocol and Software Validation
Report.
3.3 Manager / Designee from Analytical Research Department:  To review the  Software Validation Protocol and Software Validation
Report.

4.0 ACCOUNTABILITY
4.1 Manager / Designee from the Quality Assurance Department: To review the Software Validation Protocol and Software Validation
Report.
4.2 Head of Analytical Research Department and Head of Quality Assurance Department: To approve Software Validation Protocol and
Software Validation Report.
5.0 PROCEDURE
5.1 Designee from Analytical Research Department shall prepare software validation protocol before performing software validation.
5.2 The protocol shall be reviewed by the superior designee from Analytical Research Department, support engineer and the designee
from the Quality Assurance Department. The protocol shall be approved by the Head of Analytical Research Department and Head of
Quality Assurance Department.
5.3 Software validation shall be performed as per the protocol of software validation. Following parameters shall be checked while
performing software validation:
5.4 Computer Hardware Inspection
Inspect Computer hardware like CPU, connections, powder supply, On/Off switches etc.
5.5 Operating System Configuration
Under this system checkup, check actual system configuration with minimum requirements, e.g. Operating system, Processor, Hard
disk memory, RAM etc.
5.6 Workstation Configuration
5.6.1 Under this checkup, check actual workstation configuration with recommended PC configuration.
5.6.2 Record instrument details like Instrument name, model number, Serial number, Software version, Instrument number (ID) etc.
5.7 Software Validation Inspection
While validating the software, perform the inspection of the following points:
5.7.1 Operating system inspection shall be performed using following check points:
Computer boot up check
Date and time check
Hard disk check
Print drive check
Network connection test
Software version check
Program alteration check

5.7.2 Workstation software validation related to access control, Password Policies and Audit trail shall be performed using following
check points:
User Authentication and access control check 
Password log management function check 
Number of password characters check
Failed login detection
User lockout function check
Failed Login Log check 
User access rights check 
Password expiry alarm test 
Software entry attempts option, availability and cross checkup
Password expiry availability check
System policy function check
Audit trail check
5.7.3 Application software functionality shall be performed using following check points:
Method preparation check
Method edit / delete control check
 Operation qualification check
Post analysis process / reprocess check (integration, report preparation etc).
5.8 Operation wise, checkpoints to be performed can be different for different softwares and instruments. In addition to above
checkpoints, other essential checkpoints can be performed as per functionality and applicability of the software.
5.8 Software validation report shall be prepared as per protocol. Observations shall be entered in the report. The data and prints shall
be maintained.
5.9 All deficiencies shall be documented in the report.
5.10 All the corrective actions taken shall be documented in the report.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure
6.2 CPU: Central Processing Unit

 
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