The importance of inspection-readiness in handling a successful regulatory inspection of a computerized system.

1. SUCCESSFUL PREPARATION FOR REGULATORY INSPECTIONS OF
COMPUTERIZED SYSTEMS IN LIFE SCIENCES
Why is inspection-readiness so important in handling a successful regulatory inspection
of a computerized system?
Regulatory agencies often come to inspect your facility for reasons other than your Computer
System Validation 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.
These investigators have also been well trained on details of operations of 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 which can affect your
authorization to produce in a certain market/country or launch a new product (particularly with FDA
inspections). 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 or regulated
areas to successfully host and withstand focused regulatory inspections of validated computer
systems.
Why is Inspection-Readiness Important?
Inspection-Readiness is a critical element in helping to prevent regulatory citations and achieving
approvals of a new drug. It would be a mistake to believe that just doing business correctly and
meeting regulatory expectations will avoid difficulty in managing regulators. Mistakes made during

2. an inspection can quickly create the 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
– Behavior
– Documentation to review and prepare in advance of an audit
– Logistical organization
ARITHMOS Life Sciences has a team of consultants who can provide strategic support for validation
projects as well as day-to-day support for maintenance, revision and verification of activities
regarding the validation status of applications. Services include:
 Periodic compliance review of computerized systems
 Review of IT infrastructure
 Change control management
 Internal and external audit preparation