Quality Review

Verification that information in the safety database matches the primary source (e.g., reporter form, hospital record).

Departure from approved procedure or requirement; must be documented, investigated, and may require CAPA.

QC checks on case data (accuracy, completeness, consistency) before lock or submission.

Secure, computer-generated record of who changed what and when in the safety database; required for data integrity.

Principle that data is complete, consistent, accurate, and attributable (ALCOA+). Core to GxP and PV.

Process of comparing two data sources (e.g., safety database vs regulatory submission log) to ensure consistency.

Action to correct an identified deficiency (e.g., re-training, process change).

Action to prevent recurrence of a deficiency (e.g., system change, additional check).

Structured investigation to identify the underlying cause of a deviation or finding; informs CAPA.

Retention of original source documents (e.g., reporter form, hospital letter) per policy and regulation.

Metrics to monitor PV quality (e.g., submission timeliness, completeness, deviation rate).

KPIs for PV (e.g., time to report, backlog, training completion).

System for controlling documents (version, approval, distribution, obsoletion); essential for GxP.

Process for reviewing and approving changes (e.g., to systems, processes) before implementation.

Process for documenting and managing incidents (e.g., late submission, data error).

Accuracy and consistency of MedDRA (and drug) coding; affects signal detection and reporting.

Check that data are consistent (e.g., narrative vs coded, dates logical).

Check that required fields and minimum information are present.

Check that data are correct (e.g., no typo, correct code).

Attributable, Legible, Contemporaneous, Original, Accurate—principles of data integrity.

ALCOA plus Complete, Consistent, Enduring, Available—extended data integrity principles.

Verification of data against source (e.g., in trials); in PV, source document verification.

Ability to trace data from source to report and back; audit trail supports.

Difference found between two sources during reconciliation (e.g., case count mismatch); must be resolved.

Documented output of reconciliation (e.g., internal vs EV); signed off.

Long-term retention of PV records in readable form per retention policy.

A formal, documented change to a previously finalized case record, with clear rationale and audit trail.

A chronological record that traces all changes made to safety database records, including who made changes, when, and what was changed.

A systematic approach to investigating the root cause of quality issues and implementing actions to correct and prevent recurrence.

The finalization of a case record in the safety database after all processing and quality review is complete, preventing further changes without formal amendment.

The degree to which similar adverse events are coded using the same MedDRA terms across cases and processors, essential for accurate signal detection.

The percentage of regulatory submissions completed within required timeframes, a key indicator of pharmacovigilance operational performance.

A document that is formally managed with version control, approval workflows, and distribution tracking to ensure only current approved versions are in use.

The assurance that safety data is accurate, complete, consistent, and reliable throughout its lifecycle, following ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

A departure from approved procedures, regulations, or specifications that requires documentation, investigation, and potential corrective action.

The process of raising an issue or decision to higher authority when standard procedures are insufficient or when significant issues are identified.

A quantifiable measure used to evaluate the effectiveness and compliance of pharmacovigilance processes, such as timeliness, accuracy, and completeness rates.

A quality process where a colleague reviews a processed case for accuracy, completeness, and compliance before finalization or submission.

The broader systematic activities that ensure pharmacovigilance processes are performed according to established standards and regulations.

The systematic process of reviewing adverse event cases for completeness, accuracy, and compliance before regulatory submission or database finalization.

The process of comparing safety databases between parties (e.g., MAH and CRO, or MAH and partner companies) to ensure all cases are captured consistently.

A systematic investigation method to identify the fundamental underlying reason(s) for a deviation, error, or quality issue.

A documented procedure that provides step-by-step instructions for performing pharmacovigilance activities consistently and in compliance with regulations.

The process of comparing data entered in the safety database against original source documents to verify accuracy and completeness.

Documentation demonstrating that personnel have been trained on pharmacovigilance procedures, regulations, and systems before performing related tasks.

The documented process of demonstrating that a computerized system (e.g., safety database) consistently performs according to specifications and regulatory requirements.