Computer System Validation What is it? Adam Woodjetts Validation Consultant, Instem

Computer System ValidationWhat is it?

Adam WoodjettsValidation Consultant, Instem

Why Validate your Software?

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Regulatory RequirementGood “X” Practice• Collection of FDA Guidelines adopted as regulations then laws• Manufacturing, Clinical, Laboratory• 21 CFR (Code of Federal Regulations) - FDA

• Part 58 - GLP for Nonclinical Laboratory Studies• Part 11 - Electronic Records ; electronic signatures

Establishing evidence and confidence in consistent operation according to specifications• Documenting and Systematically Challenging and Testing

Reduce risk to patients

Validation of software is required to fulfil regulatory demands

Evidence of confidence in “suitability for purpose”

Demonstrating “Suitability for Purpose”

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Why do you use a specific system?• What functionality do you utilise?• How did you make the selection?

User Requirements• Clear and objective statements• Regulatory Requirements

How do you want to use the software?• Work flow diagrams• Standard Operating Procedures

Basis of Computer System Validation

User Requirements

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Risk AnalysisEstablish Importance or Impact of requirements• Grade or score each requirement using chosen method

Probability of requirement ‘Failure’• How often is it “exercised”• How Complex is the associated process

Impact of requirement ‘Failure’• Alternative methods• Production stops• Cost to resolve

Combine to get score/grade

Justification for exclusion of requirements

Prioritise or Focus testing efforts

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Testing your Requirements

Establishing environment conforms to manufactures specs (IQ)Functional Testing or Operational Qualification• Requirements mapped to manual test scripts• Automated test tools

User Acceptance Testing or Performance Qualification• Testing the workflow and operating procedures• Carried out by your users

Documentary evidence of requirement fulfilment

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Record Faults and IncidentsRecord any testing incidents• Symptoms• Cause• Consequences – Impact – Resolution

Deviations from “the Plan”• How• Why• Consequences – Impact

Environment Changes

Validation is a record of what has happened

Can the issue be ‘recreated’ with the information recorded?

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Packaging the Documentary Evidence

Create a structured Validation Plan• Environment and Installation details (IQ)• What is being testing and Why• How requirements are proven (demonstrated)

• Automated and Manual tests• Leveraging vendor Test Evidence

Summary Report• What are your findings/Conclusions? Can the software be used with confidence?• Deviations from the Validation Plan• What evidence supports your findings?

Validation Plan – What How and Why your are validating

Validation Summary Report – Demonstrate “suitability for purpose”

Questions