SOP for Software Validation : Pharmaceutical Guidelines

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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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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