The short version
What teams need to understand
- Inspectors expect literature search strategies to be documented, reproducible, and capable of identifying relevant safety information.
- Database coverage must be justified and appropriate for the medicinal products being monitored.
- Search strategies must be version-controlled and updated when safety profiles or regulatory expectations change.
- Search execution must be evidenced through logs demonstrating when searches were performed and by whom.
- Governance processes must demonstrate that literature monitoring remains effective over time.
Regulatory expectation
What regulators expect
Each expectation should be supported by controlled documentation, traceable records, clear ownership, and evidence that the process works in practice.
- Literature search strategies are documented and reproducible.
- Database coverage is justified and appropriate for the product portfolio.
- Search execution logs demonstrate that literature monitoring occurs consistently.
- Search strategies are reviewed periodically and updated when required.
- Governance oversight confirms literature monitoring remains effective.
Why it matters
What this means in practice
Pharmacovigilance literature search strategies determine how organisations identify potential safety information within the scientific literature. Inspectors assess whether these strategies are capable of identifying adverse reaction reports and whether they are controlled, reproducible, and governed appropriately. Evidence typically includes documented search strings, database coverage rationale, execution logs, and oversight demonstrating that literature monitoring remains effective throughout the product lifecycle.
Questions this page answers
Inspection evidence
Evidence teams should be able to show
Literature Search Strategy Document
- Documented search strings for each product or substance
- Defined scope of literature monitoring
- Version history for search strategies
Database Coverage Rationale
- Justification for database selection such as MEDLINE or Embase
- Documentation explaining how sources cover relevant safety information
- Evidence that literature sources are appropriate for the therapeutic area
Search Execution Log
- Logs showing when searches were executed
- Named responsible individual performing each search
- Evidence of exported search results or search outputs
Search Strategy Change Log
- Documented updates to search strings
- Rationale for changes to database coverage
- Evidence of review and approval for strategy updates
Search Governance Records
- Periodic review of search strategy effectiveness
- Governance meeting records reviewing literature monitoring
- Documentation showing that strategies remain aligned with product safety risks
Common failure patterns
What good looks like
- Search strategies are documented and reproducible.
- Database coverage is clearly justified and appropriate for the product portfolio.
- Search execution logs provide evidence that monitoring occurs consistently.
- Search strategies are periodically reviewed and updated when required.
- Governance oversight ensures literature monitoring remains effective.
How teams operationalise it
- Maintain controlled documentation for all literature search strategies.
- Record every literature search execution in a centralised search log.
- Review search strategies periodically to ensure they remain appropriate.
- Update search strategies when new safety information or regulatory expectations emerge.
- Retain evidence demonstrating that literature monitoring is functioning effectively.
From expectation to working control
Find the documentation that supports this work
Review the related toolkit to understand its purpose, included files, and how it supports this regulatory expectation.
Frequently asked questions
What databases are typically used for pharmacovigilance literature searches?
Major biomedical databases such as MEDLINE and Embase are commonly used because they provide comprehensive coverage of scientific publications.
Do inspectors require documented search strings?
Yes. Inspectors typically expect search strings to be documented so that literature monitoring can be reproduced and audited.
How often should literature search strategies be reviewed?
Search strategies should be reviewed periodically to ensure they remain appropriate for the product portfolio and emerging safety information.
Can literature search strategies change over time?
Yes. Strategies should evolve as safety information changes, but updates should be documented and controlled.
What evidence demonstrates that literature searches were performed?
Execution logs, database outputs, and timestamps provide evidence that literature searches were performed according to schedule.
What is a common inspection finding related to literature search strategies?
A common finding is the inability to reproduce historical searches due to missing search strings or incomplete documentation.
Source boundary
Regulatory sources
These primary sources inform this structured interpretation. Always confirm current requirements against the original source and the requirements applicable to your organisation, product, and jurisdiction.
European Medicines Agency
Good pharmacovigilance practices (GVP)
View sourceGVP Module VI - Collection, management and submission of reports of suspected adverse reactions
View sourceMedical Literature Monitoring
View source