Union Guidance on Record Keeping and Archiving of Documents Obtained or Resulting from Pharmacovigilance (PV) Inspections

The standardization of records management policies and procedures ensures that appropriate attention and protection is given to all records, and that the evidence and information they contain can be retrieved more efficiently, using standard practices and procedures. This guidance was prepared to standardize best practice in records management by setting the minimum requirements for document retention and record keeping for pharmacovigilance inspections.