SOP for HPLC and GC Software Validation

OBJECTIVE

To provide a procedure for software validation of HPLC and GC instruments.

SCOPE

This procedure is applicable for the software of HPLC and GC instruments used in PharmaInfo Limited.

RESPONSIBILITY

• Executive / Designee from Analytical Research Department or Support Engineer: To perform Software Validation.
• Executive / Designee from the Analytical Research Department: To prepare a Software Validation Protocol and Software Validation Report.
• Manager / Designee from the Analytical Research Department: To review the Software Validation Protocol and Software Validation Report.

ACCOUNTABILITY

• Manager / Designee from the Quality Assurance Department: To review the Software Validation Protocol and Software Validation Report.
• Head of Analytical Research Department and Head of Quality Assurance Department: To approve Software Validation Protocol and Software Validation Report.

PROCEDURE

• The designee from the Analytical Research Department shall prepare a software validation protocol before performing software validation.
• The protocol shall be reviewed by the superior designee from the Analytical Research Department, the support engineer, and the designee from the Quality Assurance Department. The protocol shall be approved by the Head of the Analytical Research Department and the Head of the Quality Assurance Department.
• Software validation shall be performed as per the protocol of software validation. 
• The following parameters shall be checked while performing software validation:

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Computer Hardware Inspection

• Inspect Computer hardware like CPU, connections, powder supply, On/Off switches, etc.

Operating System Configuration

• Under this system checkup, check actual system configuration with minimum requirements, e.g. Operating system, Processor, Hard disk memory, RAM, etc.

Workstation Configuration

• Under this checkup, check actual workstation configuration with recommended PC configuration.
• Record instrument details like Instrument name, model number, Serial number, Software version, Instrument number (ID) etc.

Software Validation Inspection

• While validating the software, perform the inspection of the following points:

Operating system inspection shall be performed using the following checkpoints:

1. Computer boot-up check 
2. Date and time check Hard disk check
3. Print drive check 
4. Network connection test 
5. Software version check 
6. Program alteration check

Workstation software validation related to access control, Password Policies and Audit trail shall be performed using the following check-points:

1. User Authentication and access control check 
2. Password log management function check 
3. Number of password characters check
4. Failed login detection
5. User lockout function check 
6. Failed Login Log check 
7. User access rights check 
8. Password expiry alarm test
9. Software entry attempts option, availability, and cross checkup 
10. Password expiry availability check
11. System policy function check 
12. Audit trail check

Application software functionality shall be performed using the following checkpoints:

1. Method preparation check 
2. Method edit / delete control check
3. Operation qualification check
4. Post-analysis process / reprocess check (integration, report preparation etc).

• Operation-wise, checkpoints to be performed can be different for different software and instruments. In addition to the above checkpoints, other essential checkpoints can be performed as per the functionality and applicability of the software.
• Software validation report shall be prepared as per protocol. Observations shall be entered in the report. The data and prints shall be maintained.
• All deficiencies shall be documented in the report.
• All the corrective actions taken shall be documented in the report.

ABBREVIATIONS

SOP: Standard Operating Procedure

CPU: Central Processing Unit

REVISION HISTORY

Nil

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