Computerised System Validation in Pharmacovigilance

Because all information technology systems directly diagnose patients Because system failures can delay reporting, impair signal detection or produce inaccurate safety analyses Because IT departments are legally prohibited from participating in validation Because validation eliminates the need for pharmacovigilance quality systems

The platform should receive one uniform validation approach because it is the same product Validation should be based on the business process and intended use supported by each implementation Only the software supplier's testing is relevant The administrative use should determine the validation strategy for the entire platform

Review individual screens without considering the signal management process Assess how the system supports signal detection, evaluation, tracking, decisions and traceability Focus only on the supplier's software development methodology Validate only the report formatting function because it is visible to users

To demonstrate that software contains no defects under any circumstances To generate documented evidence that the system remains fit for its intended use To replace the need for trained pharmacovigilance personnel To ensure that every software function receives identical testing effort

Demonstrating reliable generation, transmission, receipt and acknowledgement of submissions Demonstrating that the interface uses the newest available technology Confirming that users can change submitted records without an audit trail Confirming that all unrelated system functions have identical performance

A documented, assessed and approved change followed by proportionate regression testing An undocumented configuration change made to accommodate a new business process A completed periodic review confirming continued suitability A controlled security patch evaluated through change management

Users should begin using it while unresolved critical issues are still being assessed Validation evidence, issue resolution, acceptable residual risk, documentation approval, training and procedures should be confirmed The system should be released as soon as installation is complete All future changes should be prohibited permanently

To describe the programming language used by the supplier To define what the organisation needs the system to achieve and provide a basis for testing To document only the system's physical infrastructure To replace all operational procedures

A large initial validation package with no subsequent lifecycle records Current change controls, incident records, periodic reviews, access records and supplier oversight evidence A supplier statement that the software is compliant A single user acceptance test performed several years ago

Validation of the database automatically covers all connected systems The integrated business process may still fail even if the individual application functions correctly Interfaces are outside the scope of data integrity Gateway testing is relevant only to information technology systems