Successful Preparation for Regulatory Inspections of Computerized Systems – Part I

Why is inspection readiness so important in handling a successful regulatory inspection of a computerized system? Stefano Piccoli, Director of IT QA & Compliance Consulting Services for ARITHMOS, discusses appropriate preparation techniques in this blog series. 

auditRegulatory agencies often come to inspect your facility for reasons other than your CSV program.  However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, they are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

Furthermore, in the last decades, regulatory agency investigators have been trained by outside consultants and internally on regulatory issues regarding computer systems.

They have also been well trained on details of operations of typical key computer systems (e.g. MRP, LIMS, CDS, critical Process Control Systems, eCRF, Pharmacovigilance applications)

The result of this training is that more investigators are comfortable asking questions on this subject and they understand your systems better.

For a pharmaceutical regulatory inspection this is a crucial moment to maintain the authorization to produce in a certain market / country and to launch new products (in particular, the inspections by the FDA PAI). In this context, the preparation and readiness for inspection, including computer systems, is essential for the success of an inspection.

 What does computer inspection readiness stand for?

Computer system inspection readiness can be defined as the ability and preparedness of regulated areas to successfully host and withstand focused regulatory inspections of validated computer systems.

Why is inspection readiness important?

TILT_logo_AD_400x305Inspection readiness is a critical element in helping to prevent regulatory citations and achieving approvals of a new drug. It is a mistake to believe that just doing business correctly and meeting regulatory expectations will avoid difficulty in managing regulators. Mistakes made during an inspection can quickly create perception that you are out of control and possibly not in line with regulatory standards.

The intent of hosting the audit is not to “hide” any information from the inspectors. The intent is to ensure the correct information is supplied by the most appropriate person, in a timely manner.

There are several factors to consider when preparing for an inspection:

  • People
  • Behaviour
  • Documentation to review and prepare in advance of an audit
  • Logistical organisation

In Part I of this blog on CSV inspection readiness, I would like to start talking about the people involved. In subsequent blogs I’ll concentrate on the other factors.

The selection of the audit team for the computer systems under inspection is fundamental. It is important to select the appropriate people to be part of the inspection team in advance and keep people prepared and trained on how to handle the inspection and what behavior to have in front of the inspectors.

The following criteria should be used for the selection:

  • Competent
  • Confident
  • Credible
  • Knowledgeable
  • Honest

The following key people/roles should be selected and kept ready to present different computer systems

  • Computer validation managers. Usually they are the key speaker during inspection, as they are the more experienced and trained people on regulations about computer systems.
  • Process owners as they are using the systems according to SOPs and they are experts on the processes supported by the system. They are usually involved to explain how the system is used according to the SOPs and present user requirements and user acceptance testing.
  • System owners identified for all computer systems used at the facility/department being inspected. They are responsible to explain how the system is supported and maintained in accordance with applicable SOPs.
  • IT infrastructure representatives available to explain infrastructure processes supporting the computer system(s).

For more information on Computer System Validation processes or steps for regulatory inspection, contact us at ARITHMOS has supported numerous companies in the preparation of regulatory inspections in the clinical trial environment and can support with preparation and documentation.




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