Pharmacovigilance Literature Monitoring Pre-Audit Checklist
- 05/01/2026
Adequate preparation for a pharmacovigilance audit requires careful planning and a structured approach. One of the areas most closely reviewed during inspections is the literature monitoring process. Ensuring that this process is well organised, documented, and consistently applied is critical for demonstrating compliance with regulatory requirements. How can teams ensure their processes are compliant, efficient, and auditable? The answer lies in having a structured pre-audit checklist. Using a Pharmacovigilance Literature Monitoring Checklist allows PV teams to assess their processes, identify gaps, and ensure they are fully prepared for an audit.
If an audit is approaching (or you want to sleep better at night), this pre-audit checklist will help you spot weaknesses before the auditor does.
Why Literature Monitoring is Often Highlighted During Audits
According to the Annual Report of the Pharmacovigilance Inspectors’ Working Group for 2024, a total of 22 findings were reported in the area of adverse reaction management and reporting. Twelve of these were classified as major findings, including two related to literature screening, and two related to the receipt and collation of ICSRs from all sources at a single collection point within the EU. The remaining ten findings were minor, with several related to literature screening and ICSR collation.
These results make it clear that literature monitoring is often one of the processes most closely scrutinised during PV audits. Teams that do not have structured, documented, and regularly reviewed procedures for monitoring literature are at a higher risk of receiving observations during inspections.
Why Literature Monitoring Is an Audit Magnet
From an auditor’s perspective, literature monitoring answers three simple questions:
- Are you finding all relevant safety information?
- Are you doing it consistently and on time?
- Can you prove it – clearly and retrospectively?
Any uncertainty in those areas raises immediate red flags.
How to Use the Checklist Effectively
Before an audit, PV teams can use the Pharmacovigilance Literature Monitoring Checklist to perform a self-assessment of their literature monitoring process. Each category – search strategy, sources, source management, monitoring process, training, and reporting – should be reviewed and marked as fully compliant, partially compliant, or non-compliant. This visual assessment helps teams prioritise actions and focus on high-risk areas that auditors could highlight.
| Literature Monitoring Pre-Audit Checklist | ||||
| Category | Checklist Item | Assessment | ||
| ☐ Yes | ☐ Partially | ☐ No | ||
| 1. Literature Search Strategy | General search strategy | ☐ | ☐ | ☐ |
| Compliance with legislation | ☐ | ☐ | ☐ | |
| 2. Literature Sources | Documented source list | ☐ | ☐ | ☐ |
| Compliance with regulatory requirements (global & local literature) | ☐ | ☐ | ☐ | |
| Source selection, subscription management, selection criteria | ☐ | ☐ | ☐ | |
| Regular review and maintenance of sources | ☐ | ☐ | ☐ | |
| Backup sources available | ☐ | ☐ | ☐ | |
| 3. Source Management | Storage and archiving (electronic & paper) | ☐ | ☐ | ☐ |
| Electronic backups | ☐ | ☐ | ☐ | |
| Secure paper storage | ☐ | ☐ | ☐ | |
| 4. Literature Monitoring Process | Defined monitoring activities | ☐ | ☐ | ☐ |
| Compliance with frequency requirements | ☐ | ☐ | ☐ | |
| Assigned responsible personnel | ☐ | ☐ | ☐ | |
| Measures for uninterrupted monitoring | ☐ | ☐ | ☐ | |
| Documented monitoring procedures | ☐ | ☐ | ☐ | |
| Quality control (internal audits, metrics review) | ☐ | ☐ | ☐ | |
| 5. Training | Literature monitoring training program implemented | ☐ | ☐ | ☐ |
| Internal SOP training | ☐ | ☐ | ☐ | |
| 6. Reporting | Defined reporting process | ☐ | ☐ | ☐ |
| Retention & accessibility of reports | ☐ | ☐ | ☐ | |
| Timeliness monitored with corrective actions | ☐ | ☐ | ☐ | |
Literature Search Strategy
A strong pharmacovigilance literature monitoring process begins with a clear and documented search strategy. Regularly reviewing and updating the search strategy ensures that the team has access to the most current and relevant sources. Following a structured approach to literature search reduces the risk of missing critical safety information and demonstrates to inspectors that the process is under control.
Literature Sources
It is essential to maintain a documented list of sources, including both primary and backup sources. The rationale for selecting each source, as well as subscription management and defined criteria for inclusion or exclusion, should be clear and periodically reviewed. Ensuring that all sources comply with both global and local regulatory requirements is critical. Regular maintenance and updates to the source list demonstrate a proactive approach that auditors will look for.
Source Management
Storage and archiving practices must be established for both electronic and paper versions of the literature. Electronic backups should be tested and secure, while paper sources should be stored safely and retrievable. Demonstrating a reliable system for storing and managing sources prevents data loss and shows that the organisation can provide documentation quickly during an audit.
Literature Monitoring Process
The checklist ensures that monitoring activities are defined, assigned to responsible personnel, and carried out according to required frequency. Teams should verify that uninterrupted monitoring is possible, that procedures are fully documented, and that quality control measures, such as internal audits and metric reviews, are implemented. Auditors often focus on whether monitoring processes are consistently applied, traceable, and aligned with documented SOPs.
Training
A successful audit depends on well-trained staff. PV teams should confirm that literature monitoring training programs are implemented, that internal SOP training has been completed, and that the training depth is appropriate for the role. Training records should align with SOP effective dates and periods under review. Properly trained staff reduce the risk of errors and demonstrate competence during inspections.
Reporting
Defined reporting processes are critical. Reports must be retained in an accessible format, standardised, and monitored for timeliness. Demonstrating a structured reporting system shows auditors that the team can maintain compliance and traceability throughout the literature monitoring process.
Conclusion
A Pharmacovigilance Literature Monitoring Pre-Audit Checklist is an essential tool for PV teams preparing for inspections. It helps ensure that responsibilities are clear, SOPs reflect actual practice, sources are justified, search strategies are transparent, screening is traceable, cases are processed on time, quality control is meaningful, training is complete, and reporting is robust. By using the checklist proactively, teams not only reduce the risk of findings highlighted in the PV inspection report but also improve daily processes and strengthen overall pharmacovigilance quality.
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