Computerised System Validation in Pharmacovigilance

Relying exclusively on the supplier's marketing claims Reviewing supplier changes and maintaining appropriate quality and service agreements Allowing the supplier to define the organisation's intended use without review Removing internal change control because the supplier controls releases

The validation programme is effective because document volume is sufficient The programme may lack meaningful assurance despite extensive documentation The issue is irrelevant if the system has not yet caused a reported failure The organisation should create even more documents without changing its process

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

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

CSV addresses functionality only and has no relevance to data integrity CSV provides assurance that systems preserve reliable, complete, accurate and traceable regulated data Data integrity is assured solely by user training Regulatory compliance is achieved whenever the software supplier provides a certificate

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

Install it immediately because the vendor has already tested it Assess the change through change control and determine its impact on the validated state Repeat every historical validation test without a risk assessment Ignore it unless users report an incident

Traceability of relevant actions and changes to records Elimination of the need for access controls Guaranteed accuracy of every externally sourced record Permanent prevention of all system outages

The supplier assumes all regulatory responsibility because it hosts the infrastructure The organisation remains responsible for ensuring the system is fit for intended use and appropriately governed Validation is unnecessary because cloud platforms are standardised Only cybersecurity needs to be assessed; business functionality is excluded

They make it difficult to determine objectively whether the system satisfies the intended need They automatically invalidate every supplier qualification activity They eliminate the need for configuration documentation They affect only the appearance of the user interface