9. Services
 9.2. Audit 

The concept of audit is at the heart of the achievement of compliance with safety and functional safety standards.

Instead, the pharmaceutical industry refers to inspections. Audits are essential to qualify and validate systems, but they can also be useful for more limited and more specific aspects:

  • Analysis of Risk Reduction Strategy and Preliminary Risk Analysis
  • Analysis of the performance objectives of safety systems
  • Analysis of security specifications
  • Engineering Audit
  • Life Cycle Compliance Audit
  • Hardware and software specifications audit
  • Audit of Quality Assurance Plans for Hardware and Software
  • Software Evaluation
  • Analysis of predicted qualification / validation tests
  • Configuration Management Audit
  • Audit of document management
  • Operation and Maintenance Analysis

These audits are carried out on the basis of checklists and are concluded by the delivery of recommendations for improvement of weak points. Very often, they lead to accompanying actions to carry out pilot corrective actions, leading the implementers to the capacity to continue their compliance process. My aim is not to distribute good or bad points, but rather to provide the auditee with the keys to correcting weak points that could have been identified.