Remote Inspections

I have read many reports on the changing world we now face and how these changes affect the pharmaceutical and healthcare industries. Some changes will be short-lived; others such as remote inspections will to a greater extent remain.  Depending on the individual parties for each audit, translation services can add value to the audit process in some surprising ways.  One of the fundamental needs in preparing for a remote audit is the communication of trustworthiness and transparency. It is here that professional translations become an important partner, showing your consideration and respect whilst also smoothing out the audit process.

As a basic audit function for when documents need to be submitted in advance but are not already in English or in a nationally accepted language, then certified translations should be submitted. This smooths the pre-audit assessment. But what else can be communicated to show the values and culture of the company being audited? What demonstrates the values of your professional approach whilst also increasing audit efficiencies?

• Interpreters can be considered for the virtual meeting to ensure the gap for misunderstandings are bridged. This can be especially important for the opening and closing meetings. This also communicates the intent on being transparent, in wanting to engage in the audit and a partnership approach.
  
  
• Having presentations translated or made ready in dual language is a small consideration with a big impact.
  
  
• Having key documents readied in a bilingual format. This might only be a number of key documents from the Site Master File. In some cases, the whole SMF may need to be translated.  However, showing an approach in wanting to make life easier during audits or business meetings, tells more than the actual translation shows.
  
  
• A pre-recorded video of the manufacturing site and the company’s operations with translated voice-overs can present the auditors and also future partners with a clearer understanding of your GMP relevant areas.
  
  
• Communicating to the Auditor that sections of the audit report and follow ups are to be translated into all relevant languages for your operations, can demonstrate the interest in sharing observations and action points to your entire team, promoting the understanding of CAPAs in a more efficient way.

All of these language tools are small considerations but come with a high impact value that increases efficiency and promote savings of both valuable resources and lost opportunities.