GxPinnacle Logo
Skip to content

What Do Inspectors Check for Safety Data Exchange Reconciliation and Data Consistency?

Safety Data Exchange Agreements must include reconciliation and data consistency controls to ensure both parties hold complete and aligned safety data. Regulators expect routine case reconciliation, discrepancy investigation, duplicate control, and documented resolution of data mismatches.

For: Founders, CEOs & MDs·PV Leads·QA/Compliance·Scientists tasked with documentation

Alignment: Global pharmacovigilance principles (ICH-aligned) and inspection practices

Most useful when: Preparing for inspection, setting up a process, or closing a documentation gap

Key points

  • Safety Data Exchange Agreements must require routine reconciliation of safety data between the parties.
  • Reconciliation processes must confirm that valid cases, follow-up information, and key case attributes are aligned between systems.
  • Discrepancies such as missing cases, duplicate cases, inconsistent receipt dates, or mismatched case details must be investigated and resolved.
  • Reconciliation controls must support complete and accurate downstream regulatory reporting.
  • Duplicate prevention and case matching logic must be defined and operationally workable.
  • Inspection-ready evidence should demonstrate that reconciliation is performed, discrepancies are investigated, and data consistency is actively maintained.

What inspectors expect

Each point below should be supported by controlled documents and traceable records.

  • Safety data exchanged between parties must be complete and consistent.
  • Routine reconciliation must be performed to detect missing or mismatched cases.
  • Discrepancies must be investigated and resolved in a documented manner.
  • Duplicate controls must prevent double counting or duplicate reporting.
  • Reconciliation outcomes must support the MAH's ability to maintain a complete pharmacovigilance system.

Summary

Inspectors assess whether Safety Data Exchange Agreements include effective reconciliation and data consistency controls. They typically review case list matching, duplicate handling, discrepancy logs, and evidence that missing or inconsistent safety data is identified, investigated, and resolved promptly.

Common questions

These are the questions this page is designed to answer directly.

  • What is reconciliation in a Safety Data Exchange Agreement?
  • How do inspectors assess SDEA reconciliation?
  • Why is case reconciliation important in pharmacovigilance?
  • How do companies ensure case lists match between partners?
  • What are common reconciliation failures in SDEAs?
  • How are discrepancies investigated during pharmacovigilance reconciliation?
  • What is data consistency in safety data exchange?
  • How do inspectors verify partner case reconciliation?
  • How do you manage duplicate cases between safety databases?
  • What should an SDEA say about reconciliation?

Evidence objects inspectors expect

Reconciliation Procedure or SDEA Clause

  • Defined reconciliation frequency such as monthly or quarterly
  • Defined scope of reconciliation including initial cases and follow-up information
  • Rules for matching cases between party systems
  • Escalation requirements for unresolved discrepancies

Reconciliation Outputs

  • Case lists exchanged between parties
  • Matched and unmatched case records
  • Identification of missing cases or delayed transmissions
  • Evidence of completed reconciliation cycles

Discrepancy Logs and Investigation Records

  • Logs of missing, duplicate, or inconsistent cases
  • Investigation notes explaining root cause
  • Corrective actions taken to resolve case mismatches
  • Closure evidence for reconciled discrepancies

Duplicate Management Controls

  • Duplicate search expectations before case creation
  • Rules for handling the same case received through multiple parties
  • Documentation linking follow-up information to the correct original case
  • Prevention of duplicate reporting to authorities

Data Consistency Checks

  • Alignment of day zero and receipt dates between systems
  • Consistency of seriousness, expectedness, and causality fields where applicable
  • Matching of case identifiers and source details
  • Consistency between exchanged follow-up data and local case records

Regulatory Basis (Primary Sources)

  • GVP Module I – pharmacovigilance systems must include quality controls and oversight processes
  • GVP Module VI – ICSR collection, exchange, follow-up, and reporting must be complete and traceable
  • ICH E2D – post-approval safety data management requires complete and timely case handling
  • MHRA GPvP guidance – expectations for data integrity and compliant pharmacovigilance processes
  • FDA postmarketing safety reporting guidance – safety data must be accurate, complete, and consistently maintained

Typical Inspection Questions (What Inspectors Ask)

  • How often do you reconcile cases with your partner or vendor?
  • Show me the output from your last reconciliation exercise.
  • What happens when a case is present in one system but not the other?
  • How do you manage duplicate cases across parties?
  • How do you ensure both parties hold the same day zero and follow-up information?

Failure patterns

Reconciliation is not performed routinely despite being required in the agreement.

Case lists do not match and discrepancies remain unresolved.

Duplicate cases are created or reported more than once.

Receipt dates or follow-up data differ between systems without investigation.

Reconciliation findings are identified but not trended, escalated, or corrected.

What good looks like

  • Routine reconciliation is performed on a defined cadence and fully documented.
  • Missing or inconsistent cases are identified quickly and investigated to closure.
  • Duplicate controls are effective and understood by both parties.
  • Key case data such as day zero, seriousness, and follow-up status remain aligned across systems.
  • Reconciliation findings feed into governance, escalation, and process improvement.

Operationalisation

  • Define reconciliation scope, frequency, and ownership in the SDEA.
  • Exchange structured case lists that allow reliable matching across systems.
  • Investigate all missing, duplicate, or inconsistent cases promptly.
  • Document discrepancy resolution and confirm correction in both party records.
  • Use reconciliation findings to strengthen data quality and partner oversight.
  • Trend repeated mismatch types and implement CAPA where necessary.

Need regulatory documentation today?

Save time and reduce inspection risk with structured, pre-built process-ready documentation.
Created by industry professionals, adaptable to your organisation.

Related pre-built documentation inside the app

Get AccessLog In

FAQ

What is reconciliation in a Safety Data Exchange Agreement?

Reconciliation is the process of comparing safety data held by both parties to confirm that the same cases, follow-up information, and key case details are present and aligned.

What is case reconciliation in pharmacovigilance?

Case reconciliation is the process of comparing safety data between parties to ensure that all valid cases, follow-up information, and key case details are present, consistent, and correctly aligned across systems.

Why is reconciliation important in pharmacovigilance agreements?

Reconciliation is important because missing, duplicate, or inconsistent cases can lead to incomplete safety oversight, late reporting, or duplicate regulatory submissions.

How often should safety data be reconciled between parties?

The frequency should be defined in the agreement, but reconciliation is commonly performed monthly for active safety exchanges.

What should happen if the two parties' case lists do not match?

The discrepancy should be investigated promptly, root cause identified, the missing or incorrect data corrected, and the issue documented to closure.

Do inspectors review reconciliation outputs in pharmacovigilance inspections?

Yes. Inspectors frequently review reconciliation records to confirm that both parties maintain complete and consistent safety data.

How are duplicate cases handled in safety data exchange?

Duplicate controls should be defined in the agreement and operational process so that repeated or overlapping case reports are linked correctly and not reported twice.

Sources

Primary guidance used to inform this map. This page is a structured interpretation layer; always validate against the original source documents.

European Medicines Agency (EMA)

  • Guideline on good pharmacovigilance practices (GVP) – Module I
    View source
  • Guideline on good pharmacovigilance practices (GVP) – Module VI
    View source

International Council for Harmonisation (ICH)

  • Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)
    View source

U.S. Food and Drug Administration (FDA)

  • Postmarketing Safety Reporting for Human Drug and Biological Products
    View source

UK MHRA