How to Choose the Best Software for Literature Monitoring – A Practical Checklist

Selecting the correct software for literature monitoring is one of the most critical decisions for pharmacovigilance teams. Medical publications continue to grow every day, regulatory requirements evolve, and the need for accurate and timely safety intelligence becomes increasingly urgent. Consequently, good software can save hundreds of hours, reduce compliance risks, and improve the overall quality of safety surveillance. Poor software can do the opposite.

This practical checklist will help you evaluate and compare different solutions and choose the best software for literature monitoring for your organisation.

1. Regulatory Compliance (GVP Module VI)

Any software for literature monitoring must fully support regulatory expectations. Compliance is not optional. In fact, it is the foundation of reliable pharmacovigilance operations.

Check whether the system:

• supports monitoring of international and local journals;
• provides clear workflows for article identification, filtering, and storage;
• maintains a complete audit trail according to ALCOA+ principles;
• includes alerts and tagging for safety-relevant articles (ICSRs, signals, product issues).

For example, ask the vendor to show precisely how GVP VI requirements are implemented in the platform.

2. Coverage of Scientific Sources

Moreover, the strength of your monitoring process depends on the quality and completeness of the sources included in the system.

Evaluate whether the platform connects to:

• PubMed, Embase, CrossRef, Scopus, Google Scholar;
• local scientific journals relevant to country-specific monitoring;
• full-text access options;
• daily or weekly database updates.

Otherwise, gaps in coverage may lead to missed safety-relevant information and potential compliance risks.

3. Search Quality and Algorithm Precision

Modern software for literature monitoring should go far beyond simple keyword search. High-quality search determines whether your team receives accurate and relevant results.

Look for:

• advanced Boolean queries and proximity operators;
• automatic handling of synonyms, trade names, chemical names, and variations;
• reusable search templates for individual products;
• AI-based relevancy scoring to filter out noise;
• transparent reporting of search performance.

Without strong search capabilities, teams spend unnecessary time filtering irrelevant articles and may overlook essential findings.

4. Automation and AI Features

Automation is now essential for efficient literature monitoring. AI-powered tools automate manual reading and expedite decision-making.

Assess whether the system offers:

• AI-based preliminary relevance scoring;
• auto-generated summaries of articles;
• automatic highlighting of potential ICSRs or risks;
• extraction of key data fields (product name, indication, seriousness, outcome);
• machine learning based on your own review decisions.

Strong automation dramatically improves productivity without compromising quality.

5. Collaboration and Quality Control Tools

Pharmacovigilance is a team-driven process. Therefore, good software for literature monitoring must support collaboration and transparent workflows.

Check if the system allows:

• assignment of articles to specific safety specialists;
• QC/QA workflows with documented review steps;
• comment and discussion features;
• detailed activity logs;
• performance analytics for team leads and auditors.

A well-designed collaboration environment reduces errors and supports regulatory inspections.

6. Data Security and Risk Management

Literature monitoring may involve sensitive or confidential data. Your software must meet strong security standards.

Ensure the platform provides:

• ISO 27001 certification or equivalent security framework;
• secure cloud storage with regular backups;
• role-based access control;
• full audit logs of user actions;
• compliance with GDPR and other privacy regulations.

Security weaknesses can lead to severe compliance issues during audits.

7. Validation, Documentation, and Process Transparency

Another essential criterion when choosing software for literature monitoring is how well the system supports validation and documentation. Even if integration options are limited, transparent processes and proper validation are crucial for regulatory readiness.

Evaluate whether the platform offers:

• system validation package (IQ/OQ/PQ templates or vendor qualification documentation);
• clear description of system functionalities and workflows;
• change control documentation for every update;
• release notes that detail new features and bug fixes;
• access to SOP recommendations for implementing literature monitoring within your QMS;
• exportable logs and reports for audits and inspections.

Consequently, strong validation and transparency ensure that the software can withstand regulatory scrutiny, mitigate implementation risks, and support a consistent, well-documented pharmacovigilance process.

8. Ease of Use and User Experience

Even the most advanced system loses value if it is difficult to use. A clean and intuitive interface allows specialists to focus on safety, not navigation.

Evaluate:

• clarity of the dashboard;
• intuitive filtering and sorting;
• customisable workspaces;
• speed and responsiveness;
• mobile or web access.

User experience directly affects the speed and accuracy of literature monitoring.

9. Customer Support, Training, and Updates

Reliable support transforms software from a tool into a partnership.

Assess whether the vendor provides:

• prompt customer support with predictable response times;
• onboarding sessions for teams;
• documentation, tutorials, and SOP recommendations;
• regular system updates with new features;
• transparent communication about future development.

As a result, strong support is crucial for sustainable long-term use.

10. Cost, Licensing, and Scalability

Finally, evaluate the software’s financial and operational flexibility.

Consider:

• pricing model (per user, per product, per volume);
• availability of different packages or modules;
• hidden costs (customisation, additional users, integrations);
• scalability for future portfolio growth;
• long-term cost-effectiveness based on real use.

Ultimately, the ideal software for literature monitoring grows with your organisation.

Making the Right Choice in Software for Literature Monitoring

To help your team evaluate key aspects of any platform, we’ve therefore prepared a simple checklist. Mark ‘Yes‘ or ‘No‘ for each criterion to assess how well the system meets your requirements.

Criterion	Description	Yes	No
Regulatory Compliance	Meets GVP Module VI, supports ALCOA+, provides audit trail	☐	☐
Source Coverage	Covers both global databases (PubMed, Embase, CrossRef, Google Scholar) and local scientific journals	☐	☐
Search Quality	Advanced Boolean logic, synonyms handling, search templates	☐	☐
AI & Automation	Relevance scoring, summaries, highlighting ICSRs, auto-extraction	☐	☐
Collaboration Tools	Assignment, QC/QA workflow, comments, activity logs	☐	☐
Data Security	ISO 27001, backups, encrypted storage, role-based access	☐	☐
Validation & Documentation	Validation package, release notes, change control, workflow documentation	☐	☐
User Experience (UX/UI)	Clear dashboard, fast navigation, customizable workspace	☐	☐
Support & Training	Responsive support, onboarding, tutorials, regular updates	☐	☐
Scalability & Pricing	Transparent pricing, suitable for future portfolio growth	☐	☐

Conclusion

Choosing the best software for literature monitoring requires a structured approach and a clear understanding of pharmacovigilance requirements. Therefore, by using this checklist, you can objectively compare solutions and select the platform that most effectively meets your team’s needs.
Moreover, with the right software in place, your literature monitoring process becomes faster, more accurate, and fully compliant.

As a result, your team can focus on what truly matters: ensuring patient safety and maintaining high-quality pharmacovigilance practices.