computer system validation what is it? adam woodjetts validation consultant, instem
TRANSCRIPT
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