Revised Qbd blog

Main keyword(s) Periodic Review, CSV, computerized system

Working title What is the purpose of Periodic Reviews in
CSV?
Short summary for Google (200 characters max. Have you validated your computerized
if possible) system(s) yet? Then CSV Periodic Reviews are
an important next step. Learn more about their
purpose and frequency here.

What is the purpose of Periodic Reviews in CSV?

Current regulations require that manufacturing processes in the pharmaceutical industry be
validated, and once validated, they must be continuously monitored to demonstrate that they
remain under control, resulting in a quality product. This monitoring must be maintained throughout
the life cycle of the product to ensure quality as intended in the product design.

It should be clear that validation is never really finished, the activities simply change from Process
Design and Process Qualification to the Continuous Process Verification phase. Have you validated
your computerized system(s) yet? Then CSV periodic reviews are an important next step.

In this post, we are going to explain:

 what a CSV periodic review is,

 what its purpose is,
 and how often you should perform them.

We will also talk about the process to follow, and the minimum documentation needed to perform a
risk-based periodic review of your validated systems.

What is a ‘Periodic Review’ in CSV?

A Periodic Review is an assessment of various elements to determine the validation status and the
actions required to maintain the validated state of systems or equipment, through which we will
demonstrate and ensure that they remain fit for their intended use.

What do we mean by ‘Maintenance of Validated Status’?

To rephrase, Periodic Reviews include all actions aimed at documenting and analyzing the changes,
errors or malfunctions that a system or equipment may exhibit in order to determine whether they
maintain their validated status.

To maintain validated state, companies should include all actions to document and analyze changes,
errors or malfunctions in a system or equipment to determine whether it is still fit for purpose and
suitable for the process it serves.

Maintaining validated stateus includes continuously demonstrating through review of process data,
change control, deviations, corrective and preventive actions, and other related activities, that the
manufacturing process remains under control and results in a product that ensures quality and
patient safety.
What is the purpose of CSV Periodic Reviews?
The purpose of a periodic review is to confirm that systems are maintained in a validated state and
comply with all applicable standards and procedures throughout their operational life cycle.

Frequency of CSV Periodic Reviews

Depending on the GxP impact of your system, the frequency of the periodic review should be
determined. The minimum recommended frequency is once a year after the system or equipment is
released for productive use.

Most common elements to consider during a CSV periodic review

The most common elements to consider during a Periodic Review are:

 Previous periodic review report, as well as actions and recommendations made.

 System change history
 Maintenance records, calibration records and system usage logs
 Documentation, which includes procedures, current user training records, validation
documents and system life cycle documents
 Updated system user matrix, along with user training matrix
 Quality records, such as deviations, CAPAS, audits, change records, etc.
 System Audit Trail
 System performance

CSV Periodic Review Process

In general, the process you choose to conduct CSV Periodic Reviews should be outlined in a
standard operating procedure (SOP) with templates needed to conduct the evaluation.

Define Policy and Process

for Timing and Scheduling

Prepare for Review

Perform Review

Document Results of
Review

Perform Corrective
Actions
GAMP 5 'A Risk-Based Approach to Compliant GxP Computerized Systems', 2008.

Considerations
Finally, it is important to keep these considerations in mind regarding CSV Periodic Reviews:

 The periodic review process should be general and applicable to all systems. It should apply
to operational environments and not to development or support testing environments. The
depth and rigor of the review should be based on the impact, complexity and newness of the
system or the nature of an incident or event that triggers a review.
 Where appropriate, the Periodic Review of the IT system may be conducted as part of a
broader activity, such as the Periodic Review of a production process.
 Periodic Reviews should take into account and refer to other appropriate reviews, such as
the review of safety records, and should not duplicate activities.
 It may be useful to develop checklists for Periodic Reviews that are specific to particular
systems.
 A process for timing and scheduling reviews should be established. Review periods for
specific systems should be based on the impact, complexity, and newness of the system.
 Whatever method is chosen, the process should be documented and approved by the
management of the regulated company, and the responsibility and decision criteria should
be clearly defined. Responsibility for managing the planning and programming process and
allocating resources for revisions must also be clearly defined.

Need help?
Do you need help with the preparation of your SOP and templates for the Periodic Review of your
systems? Or would you rather have an expert support you in the complete process of periodic
reviews of all your GxP systems? QbD Group is happy to help you out! Please do not hesitate to
contact us.
Original Qbd blog
Main keyword(s) Periodic Review, CSV, computerized system
Working title Do you know what a Data Migration is about?
Short summary for Google (200 characters max. A Periodic Review is an assessment of various
if possible) elements to determine the validation status
and actions necessary to maintain the validated
status of computer systems and to ensure that
they remain fit for their intended use.

Do you know what the purpose of a periodic review of a validated

computerized system is?
Do you already have your computerized system validated? What's next? Have you heard about the
periodic review?

In this post we are going to explain what periodic review is, what is its purpose and how often you
should perform it, we will talk a bit about the process to follow and the minimum documentation
needed to perform a risk-based periodic review.

Introduction
According to current regulations, manufacturing processes within the pharmaceutical industry must
be validated, and once validated they must be continuously monitored in order to demonstrate that
they remain under control, resulting in a quality product. Such monitoring must be maintained
throughout the life cycle of the product to ensure its quality as intended in the product design.

It should be clear that validation is never really finished, the activities simply change from Process
Design and Process Qualification to the Continuous Process Verification Phase.

What does Periodic Review mean?

A Periodic Review is an assessment of various elements to determine the validation status and
actions necessary to maintain the validated state of systems or equipment, with which we will
demonstrate and ensure that they remain fit for their intended use.

What do we mean by Maintenance of Validated Status?

It is all those actions focused on documenting and analyzing the changes, errors or failures that a
system or equipment may have, in order to determine if they maintain their validated status.

Maintenance of validated status comprises the continuous demonstration through review of process
data, change control, deviations, corrective actions, preventive actions and other associated
activities that the manufacturing process remains in control and results in a product that ensures
quality and patient safety.

What is the purpose of the Periodic Review?

The purpose of a Periodic Review is to confirm that systems are maintained in a validated state and
comply with all applicable standards and procedures throughout their operational life cycle.
Frequency of Periodic Review.
Depending on the GxP impact of your system the frequency of periodic review should be defined.
The minimum recommended frequency is once a year after the system or equipment has been
released for productive use.

Most common elements to consider during a periodic review:

- Previous periodic review report, as well as actions and recommendations made.

-System change history.

-Maintenance records, calibration records and system usage logs.

-Documentation, which includes procedures, current user training records, validation documents
and system life cycle documents.

-Updated system user matrix, along with user training matrix.

-Quality records, such as deviations, CAPAS, audits, change records, etc.

-System Audit Trail.

-System performance.

Periodic Review Process

Generally, the process you choose to carry out periodic reviews should be set out in a standard
operating procedure (SOP) with templates required to carry out the review.

GAMP 5 'A Risk-Based Approach to Compliant GxP Computerized Systems', 2008.

CONSIDERATIONS
 The periodic review process should be generic and applicable to all systems. It should apply
to operational environments and not to development or support test environments. The
depth and rigor of the review should be based on the impact, complexity and novelty of the
system or the nature of an incident or event that triggers a review.

 Where appropriate, the periodic review of the IT system may be conducted as part of a
broader activity, such as the periodic review of a manufacturing process.

 Periodic reviews should consider and make reference to other appropriate reviews, such as
the review of security records, and not duplicate activities.

 It may be useful to develop periodic review checklists specific to particular systems.

 A process for the timing and scheduling of reviews should be defined. Review periods for
specific systems should be based on the impact, complexity, and novelty of the system.
  Whatever methodology is chosen, the process should be documented and approved by the
management of the regulated company, and the responsibility and decision criteria should
be clearly defined.

 Responsibility for managing the planning and scheduling process and for allocating resources
to reviews should also be clearly defined.

Do you need help to create your SOP and templates for the periodic review of your systems? Or
would you prefer a third party to support you with the complete process of periodic reviews of all
your GxP systems? We can do it for you, we have the expertise to perform these reviews. We can
support you. Do not hesitate to contact us.