SOP for Computer System Validation : Pharmaceutical Guidelines

SOP for Computer System Validation

Standard operating procedure to validate the computer system in pharmaceuticals.


To lay down the procedure for computer system validation.

2.0 SCOPE:

2.1 This SOP shall be applicable for all software-controlled instruments in the quality control department.
2.2 This procedure takes into consideration application software (not the operating system like windows), which controls the critical functions of the analytical instruments.
2.3 This procedure takes into consideration about data security features of the software & its validation.


Head QA / Designee / Assistant manager QA 


HOD Quality Assurance


5.1 Prepare & execute following documents for the software-controlled systems in the quality control laboratory.
5.1.1 Computer system validation plan Prepare a computer system validation plan, which shall be a strategic document that should state activities to be done, the scope of approach, the schedule of validation and tasks to be performed. The plan should also state the responsibilities of the validation team for performing the validation activity. Typical computer system validation plan shall contain the following:
  • Introduction 
  • Objective 
  • Scope 
  • Rationale 
  • Validation Team & responsibility 
  • Validation strategy 
  • Retrospective validation 
  • Validation process & acceptance criteria 
  • Validation support 
  • Acceptance criteria 
  • Time frame (validation schedule) 
  • Documents 
  • Computer validation review 
  • Computer revalidation 
  • Attachments (if any) Computer system validation plan shall be numbered as follows:
XXX is a serial number starting with 001.
5.1.2 Computer validation protocol The validation protocol shall include detailed steps for how to conduct the validation. It should describe serial number as well as other appropriate information about the instrument. Typical computer system validation protocol shall contain the following:
  • Objective 
  • Scope 
  • Responsibilities 
  • System description 
  • Software validation report 
  • Procedure Computer validation protocol shall be numbered as follows:
XXX is a serial number starting with 001.
ZZ is a revision number starting with 01.
New protocol will not have any revision number.
E.g. ABC/CSV-001 is a first version of the protocol i.e. without revision.
ABC/CSV-001/01 is a second version of the protocol i.e. first revision.
5.1.3 Computer validation report The validation report shall contain detailed results of the validation activities, including test results. The information and results for the validation of the software shall be compiled as a validation report. The supporting documents & printouts shall be attached to the report after putting initials & date.


SOP: Standard Operating Procedure

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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