Computerised System Validation (CSV) as per GAMP5 Guideline

Many people think that the computerized system validation is nothing but just preparation of IQ, OQ, and PQ. But this is just an incomplete way of computerized system validation. So, we have made some sections in this guide that will discuss their requirements and also make the learner or participant aware of how to do complete validation.

This course contains a total of 6 sections and 7 lectures. If you have any question/s, you can put your question/s in the comments section. I will clarify your questions.

The first section includes information about Common errors related to computerized systems. This short recording will help you understand how many professionals make errors.

The second section includes information about the cGXP Assessment of the computerized systems. This is missing in most of the computerized systems validation approaches. First, the computerized systems should be evaluated whether it is having a cGXP impact or not. Based on that further validation study and depth of validation should be decided. The training session includes below points;

Importance of topic

Know your Trainer

Role of cGXP Assessment in Pharmaceuticals

Regulatory Expectations

FDA Citations

11 Keys for cGXP Assessment

Common Errors

Take Away from the session

Q&A

The third section includes information about Vendor evaluation of cGXP computerized systems. Many pharmaceuticals only evaluate the vendors for input materials used for manufacturing the drugs and drug products. But, the cGXP computerized systems vendors also should be evaluated. This session includes;

Guideline Requirements – EU, FDA, GAMP

Vendor Evaluation Process

Risk-based Decision Making

Postal Assessment – Points to consider, when postal assessment is suitable, key points to consider during postal assessment.

Onsite Audit Assessment – Supplier Good Practices

Q&A

The fourth section includes information about the validation master plan (VMP) and also Quality Risk Management of cGXP computerized systems. This section will focus on how to prepare VMP in line with the guidelines and how to perform the QRM.

The VMP lecture includes;

Guideline Requirements – EU, FDA

Validation Guidance by FDA

7 Key Elements of VMP

VMP elements discussion in detail

Common Errors

Q&A

The lecture on Quality Risk Management includes below points;

Purpose and Scope of CSV

QRM - Guideline Requirements in Computerised Systems

Quality Risk Management – Overview

Quality Risk Management - Practical Approach

Risk Management to Evaluate Potential Impact

Risk Management within the Validation Lifecycle

Q&A

The fifth section includes information explaining how the organization should be ready for inspections.

The last section which is section six explains the business continuity and disaster recovery plan. Without this plan, the computerized system validation will not have any meaning.

These all are the prerequisites for computerized system validation.