Audit management

Managing audits

Proper audit management starts with a structured preparation program. Length and intensity will be adjusted according to site preparedness. One of the main challenges is to be able to manage intensive preparations in parallel to daily operations.
The main points are preparation, logistics and finally the management of the actual audit.

In depth preparation

  • Integrate audit feedback from other sites
  • Identify gaps to best practices
  • Ensure implementation of prior 483 commitments
  • Define action points and group them into work streams
  • Create governing structure to control implementation of work streams
  • Create documentation packages to discuss and defend topics
  • Train Subject matter experts to fully prepare them for the audit situation

Audit logistics

  • Ensure a smooth inspection flow
  • Decide on location and layout of audit facilities
  • Prepare and test request tracking model
  • Set up and test request flow
  • Set up IT systems, telephones etc.
  • Ensure smooth functioning of front- and back office
  • Plan welcome letter, transfers, hotels, walk arounds etc

Audit Management

  • Ensure a smooth flow of the audit
  • Manage investigator requests efficiently
  • Compile, distribute and manage documentation packages
  • Ad hoc preparation of presentations as needed
  • Manage final review of documentation packages
  • Flexible adjustments according to auditor preferences and focus

Follow up for sustainability

  • Manage response to audit findings
  • Define realistic commitments and CAPA’s and follow up on timelines
  • Identify root causes for audit findings and define necessary next steps
  • Build up missing capabilities and and organize additional know how
  • Develop and agree on continuous improvement program
  • Ensure continuous improvement process is put in place and followed up regularly